Category: Biosimilars
As pressure mounts on the U.S. Congress and the White House to curtail prescription drug prices, many experts continue to point to biosimilars and their promising potential to usher in competition, increase access, and drive down costs for patients—and the U.S. market is just beginning to heat up. In the latter half of 2021, there […]
German injectable medicines specialist Fresenius Kabi has made a pair of deals to kickstart its new strategic direction, including a majority stake in mAbxience that bolsters its position in biosimilars. Fresenius Kabi is buying 55% of mAbxience – a subsidiary of Spanish drugmaker Insud Pharma – for €495 million (around $550 million) upfront and undisclosed […]
Adoption of biosimilars in the US has been notoriously slow, but biosimilars manufacturers and outside observers expect this to change rapidly in the coming years. Ben Hargreaves takes a look at why uptake began slowly in both the EU and the US, and then began to accelerate to see biosimilars take a large portion of […]
I previously covered research from Dickson and Kent (2021) that examined how the entry of generic drugs impacts the price Medicare pays. In that study, the authors found that “the presence of 1 generic competitor was associated with a 14.9% mean price reduction in the bundled ASP, 2 generic competitors were associated with a 32.7% […]
Pfizer reckons it will make a whopping $22 billion in sales of its oral COVID-19 antiviral Paxlovid in 2022, with another $32 billion from its BioNTech-partnered coronavirus vaccine Comirnaty. The massive windfall revenues will drive its sales up towards the $100 billion mark – it’s estimating a range of $98 to $102 billion – up […]
By Kevin E. Noonan — On Wednesday, the U.S. Food and Drug Administration announced approval to Mylan Pharmaceuticals for a generic form of Allergan’s RESTASIS® (Cyclosporine Ophthalmic Emulsion 0.05%) product for treatment of chronic dry eye. RESTASIS® is "a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients whose tear production is presumed to […]
The pharmaceutical industry made more headlines in 2021 than in any other year in recent memory. And 2022 is set to be a monumental year as well.
Recent rumours that Biogen was about to acquired by Samsung proved unfounded, but it turns out a deal has been in preparation. The South Korean firm just agreed to buy Biogen out of their biosimilar joint venture – Samsung Bioepis – for $2.3 billion. The two companies have been partnered on Samsung Bioepis for the […]
By Kevin E. Noonan — The U.S. Food and Drug Administration approved four biosimilar drugs in 2021 under the provisions of the Biologics Price Competition and Innovation Act (BPCIA, codified at 42 U.S.C. § 262) as part of the Affordable Care Act of 2010 (colloquially known as "Obamacare"). This brings to 33 the total number […]
By Kevin E. Noonan — In September, the U.S. Food and Drug Administration issued Final Guidance entitled “Questions and Answers on Biosimilar Development and the BPCI Act: Guidance for Industry,” and Draft Guidance entitled “New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2).” The Final Guidance provides its Answers in […]
By Kevin E. Noonan — In September, the U.S. Food and Drug Administration issued Final Guidance entitled "Questions and Answers on Biosimilar Development and the BPCI Act: Guidance for Industry," and Draft Guidance entitled "New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2)." The Final Guidance provides its Answers in […]
In the latest episode of the podcast Dominic Tyer speaks with Pierre Bourdage, who’s global head of biopharmaceuticals at Sandoz about the big issues in biosimilars. They look at how biosimilars are changing healthcare and what the market looks like today, as well as Sandoz’s involvement in the area and the company’s future plans in […]
By Kevin E. Noonan — On October 15th, the Food and Drug Administration approved its second interchangeable biosimilar drug. That drug is Cyltezo (adalimumab-adbm), produced by Boehringer Ingelheim, which obtained biosimilar approval on August 25, 2017. In this recent approval, the FDA determined that Cyltezo is interchangeable with AbbVie’s Humira (adalimumab), its reference product. Cyltezo […]
Shots: Pharmapark to get exclusive rights to commercialize the therapy with a status of a local product & will be responsible for filing the report in Russia and other CIS countries The agreement will utilize Pharmapark’s sales and marketing capabilities for the ustekinumab biosimilar program in Russia & other CIS countries. Bio-Thera will lead the […]
Shots: The approval is based on the P-III VOLTAIRE-X trial evaluates the effects of multiple switches b/w Humira and Cyltezo in patients with multiple chronic inflammatory diseases The study showed that Cyltezo was equivalent to Humira & demonstrated that switching several times b/w Cyltezo and Humira resulted in no clinical differences in PK, efficacy, immunogenicity, […]
Shots: The company completes two P-III studies that compares proposed biosimilar Gan & Lee insulin glargine (GL-GLA) to a reference biologic n subjects with type 1 (n=576) and type 2 diabetes mellitus (n=567) for 26wks. The focus of the study is to assess the equivalence in treatment-induced (TI) immunogenicity between GL-GLA and the reference biologic […]
Shots: The COLUMBUS-AMD trial evaluates the clinical efficacy, safety & immunogenicity of CHS-201 (q4w for up to 48wks.) vs Lucentis in a ratio (1:1) in 477 patients with newly diagnosed subfoveal nAMD The results showed a mean BCVA improvement from baseline @8wks. with an equal median change in both treatment groups, patients experienced similar reductions […]
Shots: The US FDA has issued a notification to Polpharma Biologics for the acceptance of BQ201’s (biosimilar, ranibizumab) BLA to treat wet AMD with an anticipated PDUFA date in Aug’22 The launch of biosimilar ranibizumab may increase market competition, reduce cost & expand patient access with proven analytical & clinical similarity to Lucentis Coherus will […]
Shots: The US FDA has issued a notification to Polpharma Biologics for the acceptance of BQ201’s (biosimilar, ranibizumab) BLA to treat wet AMD with an anticipated PDUFA date in Aug’22 The launch of biosimilar ranibizumab may increase market competition, reduce cost & expand patient access with proven analytical & clinical similarity to Lucentis Coherus will […]
Shots: The US FDA has accepted the BLA for FYB201, a biosimilar referencing Lucentis for review and assigned a target action date for the application for Aug’2022 Following the approval, Coherus will commercialize FYB201 in the US whereas Formycon will participate economically in US sales through its interest in royalties paid by Coherus to Bioeq […]
When typical drugs lose their period of exclusivity, new generic competitors arrive on the market with drastically lower prices. As patients switch from brand to generic drugs, the price of treatments declines. For biologic drugs, biosimilar uptake, however, is significantly less. In part, this is because biosimilars are difficult to manufacture so the price differences […]
Shots: The approval is based on a totality of evidence including analytical, non-clinical/clinical data from the P-III study evaluates the efficacy, safety, PK & immunogenicity of SB11 (0.5mg) vs Lucentis in a ratio (1:1) in 705 patients with wet AMD The results showed LS mean change in BCVA from baseline @52wks. (9.79 vs 10.41 letters) […]
By Kevin E. Noonan — The U.S. Food and Drug Administration approved the first biosimilar drug for treating macular degeneration under the provisions of the Biologics Price Competition and Innovation Act (BPCIA, codified at 42 U.S.C. § 262) as part of the Affordable Care Act of 2010 (colloquially known as “Obamacare”). The drug is Byooviz […]
Shots: The P-III study evaluates Byooviz (0.5 mg, IVT) vs ranibizumab in 634 patients with nAMD. The results will be presented at EURETINA 2021 The 1EPs are changed from baseline in BCVA @8wks. and change in CST @4wks. with both EPs, followed by 52wks. The post-hoc analysis showed that the baseline age, BCVA, CST, and […]
Shots: Bio-Thera to receive an up front, milestones along with royalties on product sales & will be responsible for the development, manufacturing, supply of BAT1706 Sandoz to get rights for the commercialization of the therapy upon approval in the US, EU, Canada, and other countries. Bio-Thera’s BAT1706 has completed extensive biosimilar studies, including a global […]
Shots: DCGI has granted a EUA for tocilizumab in India for the treatment of COVID-19 in hospitalized adults who receives systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO Hetero’s Tocira will be marketed by Hetero Healthcare in India & manufactured by Hetero Biologics Tocilizumab (400mg/20ml) is the biosimilar referencing Roche’s […]
Shots: Bio-Thera to receive $20M up front and $130M as development and commercial milestones and will be responsible for the development, manufacturing, and supply of BAT2206 Hikma get exclusive rights to commercialize the biosimilar in the US and received first-right-to-negotiate to add Europe (excluding CIS countries) BAT2206 is a mAb, that is a proposed biosimilar […]
When is a skinny label skinny enough to protect a generic drug from claims of patent infringement? The answer remains up to interpretation after an important, controversial decision from the Federal Circuit.
Like generic drugs for small molecules, biosimilars offer the hope for reducing drug prices after biologic therapies lose their patent protections. But how big an impact do biosimilars have and how comfortable are physicians with using these substitute products? A paper by Robinson and Jarrion (2021) use data from France as a case study to […]
Shots: Polpharma has reported that its JV company, Bioeq has submitted a BLA for FYB201 (biosimilar referencing Lucentis) to the FDA. FYB201 was originally licensed from Formycon AG The launch of biosimilar ranibizumab may increase market competition, reduce cost and expand patient access with proven analytical & clinical similarity to Lucentis Lucentis is a mAb […]
By Kevin E. Noonan — Last week the U.S. Food and Drug Administration approved an interchangeable biosimilar to insulin glargine, an approval notable because it is the first approved interchangeable biosimilar product. The product is Semglee (insulin glargine-yfgn), produced by Mylan Pharmaceuticals, Inc., and under this approval, it is interchangeable with Lantus (insulin glargine) made […]
Shots: The company has signed a supply agreement for 2 anticancer biosimilars, Herzuma (trastuzumab) and Truxima (rituximab) in Brazil. The supply of Herzuma accounts for ~80% of Brazil’s trastuzumab market Additionally, the company also won orders from eight state governments in Brazil for Truxima, including a bid in Sao Paulo. Following this, the company plans […]
Shots: The US FDA has approved Semglee (insulin glargine-yfgn injection) as the first interchangeable biosimilar product under the 351(k) regulatory pathways to treat diabetes Semglee will allow pharmacy level substitution for the reference product, Lantus across the US & will be launch before the end of 2021. Biocon is eligible to have exclusivity for 12mos. […]
Shots: Meiji and Dong-A ST to receive an upfront & will be eligible to receive development & sales milestones along with profit share. The companies collaborated to commercialize DMB-3115 proposed biosimilar to ustekinumab for the treatment of inflammatory diseases such as PsO, CD & UC Intas to get exclusive license rights to commercialize DMB-3115 globally, […]
Shots: NMPA has granted approval to market infliximab biobetter in China. Sorrento holds exclusive commercial rights to Infliximab biobetter Ab outside of China and plans to file a BLA for the product in the US and EU in 2021 Biobetters are drugs that have similar structure and properties to an innovator product but are enhanced […]
Shots: The company initiates P-III clinical trial to evaluate the efficacy, safety, tolerability, PK, and immunogenicity of SB17 vs Stelara in a ratio (1:1) in patients with moderate to severe plaque psoriasis Additionally, patients either continue on Stelara or transition to SB17 @28wks. The IPs (SB17 or Stelara, q12w) will be administered @0, 4 and […]
Shots: The first patient has been dosed in a P-III clinical study evaluating the efficacy and safety of BAT2206 vs reference Stelara in ~ 472 patients with moderately to severely PsO BAT2206 represents the 4th biosimilar of Bio-Thera’s portfolio to enter P-III study. The advancement of BAT2206 in P-III study demonstrates company’s commitment to develop […]
Shots: The companies collaborated to commercialize the first biosimilar Darbepoetin alpha in the GCC market for the treatment of anemia associated with chronic renal failure. The CKD biosimilar is currently approved in South Korea The collaboration with CKD helps to build the biosimilar footprint in the Middle East and Africa markets to reach more people […]
Last Friday, President Biden released an executive order titled “Promoting Competition in the American Economy” While the order talk about transportation, internet companies, and farming, there were a number of provisions related to health care. I summarize each of these below. Specifically I review OTC hearing aids. Currently, many patients need to visit a doctor […]
Shots: Polpharma Biologics has reported that its JV company, Bioeq collaborates with Teva to commercialize Bioeq’s FYB201 (biosimilar referencing Lucentis) in the EU, Canada, Israel & New Zealand The launch of biosimilar ranibizumab may increase market competition, reduce cost and expand patient access with proven analytical & clinical similarity to Lucentis while FYB201 was originally […]
Shots: The first patient has been dosed in the comparative, confirmatory efficacy, and safety AVT04-GL-301 clinical study to evaluate AVT04 vs Stelara in ~ 530 patients with plaque psoriasis across five countries in the EU The purpose of the study is to demonstrate therapeutic equivalence b/w AVT04 and Stelara in terms of safety, efficacy, and […]
Shots: The company reported that all the P-I studies assessing insulin aspart (GL-ASP), insulin lispro (GL-LIS), and insulin glargine (GL-GLA) met their primary PK & PD analyses and demonstrated that PK/PD bioequivalence b/w each of the proposed biosimilar and their respective reference compounds The safety profiles were comparable b/w each of the three proposed biosimilar […]
Shots: The P-III Xplore study involves assessing ranibizumab biosimilar vs Lucentis in 583 patients. The study met its 1EPs demonstrating the equivalent efficacy in BCVA @ 8wks. treatment Additionally, the interim analysis of 6mos. data demonstrated that the biosimilar has a similar PK, safety, and immunogenicity profile compared to Lucentis. The companies plan to submit […]
Shots: Formycon and Bioeq have submitted MAA for FYB201 (biosimilar referencing Lucentis) to EMA Teva will responsible for the commercialization of FYB201 in the EU which has acquired the distribution rights under its collaboration with Bioeq. Currently, Formycon has four biosimilars in development Formycon focuses to treat ophthalmology, immunology, and other key chronic diseases covering […]
Shots: The new data from the post-approval study evaluates the effectiveness & safety of Truxima (CT-P10) in patients with DLBCL in a real-world setting across Europe Results: @30mos. post-index, 67% had not experienced disease progression with OS (74%), three-quarters patients achieved complete or partial response @30mos., well tolerated with AEs while response rates, survival rates […]
Shots: The company has initiated a P-III clinical study to evaluate the efficacy and safety of BAT2506 vs Simponi in ~ 480 volunteers with PsA. Simponi is approved for moderately to severely active RA, active PsA, active AS & UC BAT2506 is the 3rd proposed biosimilar of the company to enter a global P-III study […]
Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients During the month of May, Samsung initiated patient enrollment in the P-III […]
Shots: The US Supreme Court has denied Sandoz’ petition to review Federal Circuit’s July 2020 decision concerning the Sandoz biosimilar Erelzi (etanercept-szzs) for the reference product, Enbrel (etanercept) The company was unable to launch the product in the US due to patent litigation. The affordable biosimilar will not be available in the US till 2029 […]
Shots: Quebec will follow a similar approach to policies introduced in British Columbia, Alberta and recently in New Brunswick to transition patients who use a reference biologic to a biosimilar. This will contribute to annual savings that can be reinvested in healthcare and innovative new drugs The transition will take place under the supervision of […]
Shots: Quebec government has stated province intention to shift towards biosimilars and follows the transition policies implemented by British Columbia, Alberta & New Brunswick The expanded use of biosimilars is expected to generate annual savings of $100M for the public drug insurance plan and its insured parties that can be reinvested in healthcare and innovative […]
Shots: Xbrane to initiate a new biosimilar development program annually and planning to generate positive operating cash flow monthly on the back of expected Xlucane net-income by late 2023/early 2024 Xlucane (biosimilar, ranibizumab) referencing Lucentis is currently in the P-III trial with expected results in mid-2021, regulatory submissions are underway in the EU in Q3 […]
Shots: Prime Therapeutics launches MedDrive in multiple phases and provide a solution to help Blue Plan clients for greater biosimilar adoption and drug cost-saving strategies Prime helps the Blue Plan clients through a 100% transparent, unbiased PBM model that serves nearly 33M members across 23 Blue Plans Prime and Blue Cross plans to improve the […]
Shots: The P-III study involves assesing the safety, efficacy, immunogenicity & PK of BAT1806 vs Actemra/RoActemra (tocilizumab) in 621 patients with the mod. to sev. RA with inadequate response to methotrexate The study met its 1EPs that demonstrated equivalent efficacy and comparable safety profile to the Actemra/RoActemra. The 1EP of the study was ACR20 Biogen […]
Shots: The US FDA has accepted the BLA for a proposed biosimilar to Neulasta (pegfilgrastim) by filing using the 351(k) pathway The BLA submission is based on similarity data from analytical, PK, PD, and immunogenicity studies. The focus is to provide affordable solutions to reduce the disease burden The US FDA filing is the first […]
Shots: The P-III CT-P17 3.1 trial involves assessing Yuflyma (adalimumab, 40mg, high-concentration formulation, low-volume and citrate-free, q2w, up to 24 wks.) vs reference adalimumab in a ratio (1:1) in 648 patients with active RA The one year data demonstrated comparable efficacy of Yuflyma to reference adalimumab in terms of ACR20/50/70 response rates in patients receiving […]
Shots: The company initiate a pivotal PK P-I clinical trial assessing the efficacy of BFI-751 vs Stelara in healthy human volunteers, with the authorization of Ethics Committees in both Australia and New Zealand The primary objective of the study is to compare PK of BFI-751 to US & EU-Stelara following a single dose under the […]
Biosimilars firm Alvotech has filed a lawsuit that challenges AbbVie’s legal defences surrounding the inflammatory disease drug Humira in the US. Alvotech is challenging the patent thicket surrounding Humira, a common ploy in pharma that seems to be particularly effective in the US. Several biological drugs have remained unchallenged on the US market thanks to […]
Shots: The company reports the availability of Amgevita, referencing Humira to treat 11 chronic inflammatory conditions in Canada Amgevita is available as a prefilled syringe and a prefilled pen (SureClick autoinjector) with a broad range of pack sizes to support dosing for each indication and available in a citrate-free formulation. Amgevita is reimbursed on the […]
Shots: The company starts enrolling patients in the P-III MYLIGHT study to evaluate the safety and efficacy of biosimilar aflibercept vs Eylea in patients with nAMD for 48wks. The study is expected to enroll 460 patients across 20 countries The study is a part of a biosimilar development program that includes analytical, pre/ clinical data. […]
Shots: The company reported the results from a study based on the structural and functional analysis of SB11, a proposed biosimilar referencing Lucentis (ranibizumab) The analytical assessment demonstrated that structural, physicochemical characterization i.e. amino acid sequence, post-translational modifications, higher order structure, and size and charge variants of SB11 were similar to Lucentis The SB11 is […]
Shots: The EC has approved the Abevmy (100 & 400mg) for the treatment in metastatic colorectal carcinoma, metastatic breast cancer, NSCLC, glioblastoma, ovarian, cervical, and renal cancer as part of a specific regimen The approval follows CHMP’s positive opinion and is valid in all EU Member States as well as in the EEA countries Iceland, […]
Shots: Pharmapark to get exclusive rights to commercialize HD204 and is responsible for local registration, sales, and marketing of the biosimilar in Russia in collaboration with Russian import substitution strategy Prestige BioPharma will be responsible for commercial supply the product out of its manufacturing facilities in Osong, Korea Prestige’s (HD204) is currently being evaluated in […]
Shots: The agreement facilitates PlantForm’s collaborations in Brazil to provide affordable, effective cancer drugs to millions of Brazilians The 3yrs. research and development collaboration will culminate in protocols for P-I and P-III clinical trials. The companies will take biosimilar pembrolizumab to world markets, following the completion of clinical trials in Brazil Pembrolizumab is a biosimilar […]
Shots: Bio-Thera to receive $30M up front following the achievement of P-III satisfactory results and is eligible for commercial milestones along with royalties. The transaction is expected to close in Q2’21 Biogen to get exclusive regulatory, manufacturing, and commercial rights of BAT1806 in all countries excluding China (includes Hong Kong, Macau, and Taiwan) Biogen will […]
Shots: The EC has approved MB02 biosimilar to Avastin (Bevacizumab) in the EU for the treatment of carcinoma of the colon or rectum, BC, NSCLC, RCC, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix Mabxience’s MB02 to be marketed as Alymsys and Oyavas both show comparable quality, safety & efficacy […]
Shots: Samsung Bioepis in collaboration with Merck broadens its global reach by launching Hadlima in Australia for multiple autoimmune diseases With the launch in Australia, Samsung Bioepis’ adalimumab is now available in three markets: Europe, Canada, and Australia Hadlima is Samsung Bioepis’ third anti-TNF biosimilar launched in Australia, following the launch of Brenzys (etanercept) and […]
Shots: The P-III trial involves assessing the safety, immunogenicity and PK of EG12014 (trastuzumab, biosimilar) vs Herceptin in 807 patients in a ratio (1:1) for HER2-positive breast cancer The trial met its 1EPs showed equivalent efficacy to Herceptin in regards to clinical response (pCR) in both analysis populations (per-protocol and full-analysis sets) and demonstrated a […]
Shots: The US FDA provide feedback on the pivotal trial protocol and statistical analysis plan (SAP) for the development program of biosimilar insulin glargine candidate, which the company plan to launch in 2023 The US FDA has requested Lannett to submit a protocol for the pivotal trial for review before IND submission. Lannett plans to […]
Shots: The company has completed a P-I trial that assessed ALT-L9 vs Eylea in 28 patients in a ratio (1:1) with neovascular (wet) AMD. The trial was conducted at 4 major hospitals in Korea The safety & efficacy of ALT-L9 were similar to Eylea and the results showed similar improvement effects in BCVA and CST. […]
Shots: The CHMP has adopted a positive opinion recommending the marketing authorization of Abevmy (inj. bevacizumab 100 & 400mg), which is co-developed by Biocon and Viatris The companies expect the EC’s decision in May’2021, which will grant the approval in 27 EU member countries and EEA member states of Norway, Iceland and Liechtenstein. For the […]
Shots: The P-I study assesses the PK, safety, tolerability and immunogenicity of SB17 vs Stelara (US & EU sourced) in 201 healthy males in a ratio (1:1:1) aged 18-55yrs. All IPs will be administered subcutaneously in the abdomen Samsung Bioepis has four biosimilar candidates – SB12 (eculizumab), SB15 (aflibercept), and SB16 (denosumab) in P-III and […]
2021 will be the year when big market access changes – including the far wider use of health economic evaluation – are implemented in Spain. In the latest of a suite of features looking at the biggest markets in Europe, Leela Barham takes stock of what 2021 could bring for market access in Spain. Higher […]
Shots: Health Canada has authorized Idacio on Oct 30, 2020, for marketing in Canada and is now available for all indications of the reference (Humira) in the field of rheumatology, gastroenterology and dermatology Health Canada’s approval was based on analytical, pre/ clinical data that demonstrated similar PK, efficacy, safety and immunogenicity to the Humira. Idacio […]
Shots: The US FDA has accepted the BLA under the 351(k) for CHS-1420 with an anticipated BsUFA date as Dec’2021 The company plans to launch the CHS-1420 in the US on or after Jul 01, 2023 as per the terms of an agreement with AbbVie Coherus collaborated with Junshi in Feb’2021 to in-license toripalimab in […]
Shots: The EC approval follows CHMP’s positive recommendation for Yuflyma (high concentration formulation) granted in Dec’2020. The approval covers all 13 intended indications to treat multiple chronic inflammatory diseases The approval is based on analytical, pre/ clinical studies, demonstrating that Yuflyma is comparable to the reference product, in terms of safety, efficacy, PK/PD, and immunogenicity […]
Shots: The EC approval follows CHMP’s positive recommendation for Kixelle to treat DM in adults, adolescents, and children aged ≥1yr. The biosimilar has been approved as a 100 units/ml solution for injection in vial & pre-filled pen presentations The EC’s CMA is valid in all EU Member States as well as in the EEA countries […]
Shots: The companies collaborated to co-develop Insulin aspart while Lannett granted exclusive US commercialization rights of insulin aspart to HEC Lannett will fund the clinical development requirements and will manage the clinical & regulatory steps specific for the FDA’s approval while HEC continues to develop the product and related manufacturing infrastructure. Both companies will share […]
Shots: The company received DCGI’s MA for Teriparatide (biosimilar) for the treatment of Osteoporosis vs anti-resorptive therapies such as bisphosphates and SERMs The approved product will be marketed through Alkem Laboratories as well as it explore other potential partnering opportunities Teriparatide will be launched in a fully compliant pen device Click here to read full press […]
Shots: Biocon and Clinton Health Access Initiative collaborate to expand the offering of oncology biosimilars in over 30 countries including Africa and Asia as a part of the Cancer Access Partnership (CAP) The collaboration strengthens Biocon’s mission to address unmet needs of patients in Asia and Africa for advanced cancer therapies via cost effective biosimilars. […]
Shots: The Health Canada has granted a NOC which is based on clinical evidence for Remsima/CT-P13 SC vs CT-P13 IV up to 1year in patients with RA. The results demonstrated that switching patients from Remsima IV to its SC formulation @30wks. is comparable to maintaining Remsima SC up to 54wks. The therapy has shown similar […]
Shots: The BLA submission is based on data from P-III clinical comparison study that demonstrated BAT1706 is highly similar to reference bevacizumab in clinical efficacy, safety, and immunogenicity. The anticipated BsUFA date is Nov 27, 2021 The BLA seeks approval of BAT1706 for mCC in combination with fluorouracil-based CT, 1L treatment for nsq. NSCLC, recurrent […]
Shots: Innovent to receive milestones for development and commercialization along with royalties on net sales of the therapy in the licensed territory. Etana is committed to launch Byvasda in Indonesia The collaboration will enable Byvsada to penetrate into a Southeast Asian market and allow Innovent to bolster its presence globally In Jan’2020, Innovent signed an […]
Shots: Henlius reported that NMPA has approved the IND application of HLX15 for the treatment of multiple myeloma The company has compared HLX15 in a head to head study with reference daratumumab via analytical & preclinical studies. The results demostrated that HLX15 is highly similar to reference daratumumab The company has developed the HLX15 in […]
In this second ‘Nine for 2021‘ article, IQVIA’s Sarah Rickwood looks at four issues which will directly impact pharma in 2021: the permanent changes in customer engagement models, the implications of a geographic re-balancing towards the East, CNS as the new value growth area for the 2020s, and the new biologics environment as biosimilars accelerate. […]
Shots: Kamada signs an agreement with two undisclosed international pharmacies to commercialize three biosimilar product candidates in Israel. The two pharmaceutical companies will be responsible for the development, manufacturing, and supply of three products Following the approval from EMA and IMOH, the three products are expected to be launched in Israel b/w 2022 and 2024 […]
Shots: The EMA Submission is based on P-l CHRYSALIS study to evaluate the safety and efficacy of Amivantamab as a monotherapy and in combination with Lazertinib in adult patients for the treatment of advanced NSCLC Result of CHRYSALIS Study assessed efficacy using overall response rate per Response Evaluation Criteria, CBR, DOR and PFS as well […]
Shots: Cullinan will receive $20M up front and is eligible to receive ~$211M in development, regulatory and sales-based milestone payments Cullinan is also eligible for high-single-digit to low-teen tiered royalties based on sales of CLN-081 in Greater China includes Hong Kong, Macau and Taiwan CLN-081 is an orally available, small-molecule, irreversible EGFR inhibitor, which is […]
Shots: The approval is granted in pediatric plaque psoriasis and non-infectious intermediate uveitis, posterior uveitis and panuveitis in adults, who do not respond adequately to corticosteroids. These are fifth and sixth approved indications of Sulinno in China and it was first approved by NMPA on Sep 2, 2020 Sulinno is an adalimumab biosimilar which is […]
Shots: The approval is based on trial assessing Riabni (375 mg/m2, IV) vs Rituxan once weekly for 4wks. followed by dosing @12wks. & 20wks. in 256 patients in a ratio (1:1) with grade 1, 2, or 3a follicular B-cell NHL & low tumor burden The WAC of Riabni will be 23.7% lower than the Rituxan […]
Shots: Health Canada has authorized Hyrimoz on Nov 4, 2020 for marketing in Canada. Hyrimoz has been approved for use in all same indications as reference Humira, including rheumatology, gastroenterology and dermatology A patient support program will be available to patients treated with Hyrimoz providing guidance with reimbursement navigation, financial assistance, administrative support & education […]
Shots: The P-lll study will assess the efficacy, safety, pharmacokinetics PK/PD, and immunogenicity of SB16 vs Prolia in 432 female volunteers for postmenopausal osteoporosis The company has initiated the P-I study to compare the PK/PD, safety, tolerability, and immunogenicity b/w SB16 and Prolia in healthy volunteers in Oct’2020 Samsung Bioepis has three biosimilar candidates – […]
Shots: The agreement strengthens the ongoing collaboration b/w the companies signed in 2018 to commercialize Alvotech’s biosimilar portfolio in Japan Fuji Pharma currently owns a minority stake in Alvotech and now can enter new therapeutic areas following the agreement With the extension of the agreement, Fuji Pharma has a leading biosimilar pipeline in Japan. Fuji […]
Shots: The company has submitted an MAAA for BAT1706 to EMA. Bio-Thera seeks a commercial license for all approved indications of bevacizumab in the EU Member States, Iceland, Norway, and Liechtenstein The submission of the MAA for BAT1706 marks it as the first ex-China MAA/ BLA submission. The BLA of the biosimilar for metastatic carcinoma […]
Novartis’ pipeline is strong enough to overcome a $14 billion patent cliff as blockbuster drugs face generic competition in the coming years, analysts have said. Following a briefing with management, a team of analysts led by Peter Welford said that the big Swiss pharma will be propped up by its psoriasis and infectious diseases blockbuster […]
Shots: The companies collaborate with the Yangtze to commercialize eight biosimilars in China. The initial pipeline contains biosimilar candidates for the treatment of autoimmunity, ophthalmology, and oncology Alvotech and Alvotech & CCHT will be jointly responsible for the development, registration, and supply of biosimilars in China while Yangtze River Pharmaceutical will exclusively commercialize the biosimilars […]
Shots: The P-lll ORIENT-32 study involves assessing of Tyvyt (sintilimab) + Byvasda vs sorafenib as a 1L treatment in 571 patients in a ratio (2:1) with advanced HCC and the result were released in an oral presentation at the ESMO Asia Virtual Congress 2020 Result: Reduction in risk of all-cause mortality (43.1%); the median OS […]
Shots: The US FDA has accepted the BLA of AVT02 for review and is expected to decide on the filing in Sept’2021 while the EMA has accepted for review an MAA for AVT02 with an EMA decision anticipated in the Q4’21 The filings were based on AVT02-GL-101 & AVT02-GL-301 studies demonstrating a high degree of […]
Novartis/Genentech’s eye drug Lucentis could be the next big blockbuster to face competition from cheaper biosimilars after its US patent expired this year – and Samsung Bioepis and Biogen are closing in after the FDA accepted a filing for their cut-price rival. Lucentis (ranibizumab) was first FDA approved in 2006 for wet age-related macular degeneration […]
Shots: The NMPA has accepted HLX15’s IND to be used in the treatment of multiple myeloma. HLX15 is Henlius’ second self-developed product around blood tumor treatment The company evaluated the biosimilar in a head to head clinical studies demonstrating that HLX15 is highly similar to its reference daratumumab while the safety profiles are also similar […]
Shots: Teva to get an exclusive right to commercialize Tuznu in Israel, leveraging its marketing capabilities and experience in bringing pharmaceutical products to market and will be responsible for local registration, sales, and marketing in Israel Prestige will assume responsibility for product registration with the EMA and commercial supply of Tuznue from its manufacturing facilities […]
Shots: The P-I study assesses the PK/PD, safety, tolerability of SB16 (denosumab) vs Prolia in 168 healthy male volunteers for osteoporosis. The study will be 3 arms study that involves dosing with SB16 either the EU or US-sourced Prolia The proposed biosimilar references Amgen’s Prolia which was approved in 2010 for osteoporosis with a high […]
Shots: The first patient has been dosed in a P-I study of HLX14, conducted in 2 parts, Part 1 is a pilot study assessing PK/PD, safety, tolerability & immunogenicity of HLX14 vs EU-sourced denosumab (SC) in healthy male volunteers Part 2 is a four-arm study assessing the bioequivalence of HLX14 vs US-, EU-, CN-sourced denosumab. […]
Shots: Alvotech and Cipla entered an exclusive partnership to provide patients with better access to high quality and cost-effective biosimilar medicines in South Africa Alvotech will be responsible for the development and supply of the products and Cipla will be responsible for the registration and commercialization The biosimilar portfolio will include five biosimilars- two for […]
Shots: Formycon & Bioeq reported the BLA resubmission strategy for FYB201 (biosimilar referencing Lucentis) has been adjusted With the revised submission strategy, the companies expect a simplification of the approval procedure. The modified submission dossier is anticipated to be filed with the US FDA in H1’21 The adjustment of the regulatory strategy while optimizing the […]
Shots: The P-III study involves assessing CT-P17 (40mg, q2w) vs reference adalimumab for up to 24wks. in 648 patients with active moderate-to-severe RA despite MTX treatment Results demonstrated that CT-P17 has equivalent efficacy to reference adalimumab i.e. ACR20 is 82.7% for both, 2EPs include ACR20/50/70 response rates, mean DAS28, CDAI & SDAI & EULAR (CRP) […]
Shots: The company reported results from two real-world studies of Renflexis (infliximab-abda) in patients with IBD registered in the US Veteran Affairs Healthcare System database. Data were presented at ACG 2020 One study assesses the safety of switching from reference infliximab or infliximab-dyyb to Renflexis in patients with IBD identified from the VAHS database and […]
Shots: The P-I clinical trial involves assessing of a single dose of either NeuLara, US- or EU-sourced Stelara in ~200 healthy volunteers. NeuLara is NeuClone’s second biosimilar to have met all 1EPs & 2EPs in a three-arm P-I study Result: the study met all co-primary PK endpoints for Cmax and AUC. For all PK 1EPs, […]
Shots: Henlius to receive upfront, regulatory, and commercial milestone payments of ~$43M, eligible to receive $30M for every $1B above the first $600M of the cumulative net sales along with 10% royalties on net sales of the therapy Henlius will be responsible for the pre/ clinical development of HLX04, whereas Essex is responsible for regulatory […]
Roche’s pharmaceutical revenues have been hit by falling sales in its pharma division in Q3 but a spike in demand for COVID-19 tests spared the Swiss company’s blushes. Sales of its “big three” cancer drugs were all down considerably in Q3 as cheaper biosimilars gained market share in the US. Avastin was down 30% compared […]
Shots: EMA has accepted to review the Marketing Authorisation Application for SB11, a proposed biosimilar referencing Lucentis (ranibizumab). If approved, SB11 will join a growing number of biosimilars developed by Samsung Bioepis and commercialized by Biogen In Nov 2019, Samsung Bioepis announced that it entered into a new commercialization agreement with Biogen for two ophthalmology […]
Shots: Henlius to receives $27M up front, ~$13M regulatory milestones, $25M commercial milestones for every $500M of cumulative net sales, and is eligible to receive royalty up to 50% profit of HLX02. If the cumulative net sales of HLX02 reaches $3B, Henlius to receive ~$150M as commercial milestones Accord to get an exclusive license to […]
Shots: The companies launch Nepexto, a biosimilar referencing Amgen’s Enbrel, and is indicated for the mod. to sev. RA, JIA from the age of 2yrs., active and progressive PsA, severe axSpA, mod. to sev. PsO and chronic severe PsO in children and adolescents from the age of 6yrs. Nepexto is available as a solution for […]
Shots: Bio-Thera to receive $165M upfront, regulatory, and commercial milestones and is eligible to receive royalties on sales of the product. BeiGene to get the right to develop, manufacture, and commercialize BAT1706 in China, including Hong Kong, Macau, and Taiwan while Bio-Thera will retain rights for the therapy outside the licensed territory The NMPA has […]
Shots: Bio-Thera to receive $165M upfront, regulatory, and commercial milestones and is eligible to receive royalties on sales of the product. BeiGene to get the right to develop, manufacture, and commercialize BAT1706 in China, including Hong Kong, Macau, and Taiwan while Bio-Thera will retain rights for the therapy outside the licensed territory The NMPA has […]
Shots: On Aug 14, 2020, HLX02 (biosimilar, trastuzumab) received NMPA’s approval to treat HER2+ early BC, HER2+ m-BC and HER2+ m-gastric cancer. Additionally, On 27th July, HLX02 has received EC’s approval under the brand name Zercepac Henlius followed the NMPA and EMA’s biosimilar guidelines and has taken multiple head-to-head comparisons b/w HLX02 and the reference, […]
Shots: The company launches its first oncology treatment Ontruzant (trastuzumab), a biosimilar referencing Herceptin in Brazil. The biosimilar has received ANVISA’s approval for the treatment of metastatic HER2-overexpressing BC, early HER2-overexpressing BC, and advanced gastric cancer Ontruzant is being supplied to SUS through a PDP b/w Samsung Bioepis & Bionovis and Bio-Manguinhos. This the second […]
Shots: Cadila has launched NuPTH an osteoporosis biosimilar of Forteo in India. The NuPTH is used for the treatment of osteoporosis and in patients with increased risk of fracture. The biosimilar NuPTH aims to be cost-effective for patients and will be available as easy to use, pre-filled disposable pen NuPTH is the third biosimilar launched […]
Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency. Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients. Hence, the providers are more likely to adopt biosimilars as a “reference […]
Shots: Alvotech will lead the development, registration, and supply of the biosimilars, while Teva will be exclusively commercializing the products in the US. Alvotech will receive upfront with subsequent milestone payments over the next several years The companies will share the profit from the commercialization of the biosimilars. The collaboration leverages Teva’s commercial presence and […]
Shots: The approval is based on comparative quality studies, clinical studies including preclinical data and resulted in bio-similarity, comparable efficacy and safety of Zercepac (HLX02) vs Herceptin Zercepac is developed under NMPA and EMA biosimilar guidelines and has been evaluated with the reference trastuzumab including comparative quality studies, preclinical studies, a P-I clinical study and […]
Shots: The EMA’s CHMP has adopted a positive opinion recommending the MAA of Centus’ Equidacent (bevacizumab), a biosimilar to Roche’s Avastin to treat carcinoma of the colon or rectum, breast cancer, NSCLC, RCC, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix Equidacent will be available as 25 mg/ml as the […]
Shots: NCCN and Pfizer have issued an open RFP that develop and validate enduring approaches to improve the safe, effective, and efficient adoption of biosimilars in oncology The RFP supports approaches to improve the processes related to biosimilar adoption in oncology. Letters of Intent are welcome from academic or community centers, patient advocacy groups and […]
Shots: The P-III study involves assessing of SCB-808 vs Enbrel in patients with AS (axSpA) via SC administration SCB-808 is being developed in the prefilled syringe formulation which is ready for injection and can be self-administered by the patients, thus overwhelming the current Enbrel biosimilar which are available in lyophilized powder formulation in China Clover […]