Insights+ Key Biosimilars Events of October 2020

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 product to biologics” possessing similar therapeutic properties. During the month of October, Henlius signed two agreements for its biosimilar products and presented results of HLX03 (biosimilar, adalimumab) whereas Samsung Bioepis and Biogen announced EMA filing acceptance of SB11 (biosimilar, ranibizumab). Our team at PharmaShots has summarized 09 key events of the biosimilar space of Oct 2020.

1. Henlius Signed an Exclusive License Agreement with Accord for HLX02 (biosimilar, trastuzumab) in the US and Canada

Published: Oct 01, 2020

Product: HLX02 (biosimilar, trastuzumab)

  • 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 develop and commercialize HLX02 in the US & Canada. The development process strictly followed the EMA and NMPA’s biosimilar guidelines
  • In 2018, the companies enter into a license agreement, under which Henlius granted Accord UK exclusive commercialization rights of HLX02 in the EU, the Middle East, North Africa, and the Commonwealth of Independent States. The therapy received EC’s and the NMPA approval sin July & Aug’2020, making it the first China-developed mAb biosimilar approved both in China and in the EU

2. Medicure Signed Agreement with Reliance Life Sciences for Marketing Rights of a Cardiovascular Biosimilar

Published: Oct 05, 2020

Product: Biosimilar

  • Medicure is responsible for the regulatory approval process for the product
  • The agreement grants an exclusive right to Medicure to market & sell the product in the US, Canada & the EU
  • The product fits well with Medicure’s mission of being a significant CV company focused on the US market

3. Samsung Bioepis and Biogen Announce EMA Filing Acceptance of SB11 (biosimilar, ranibizumab)

Published: Oct 07, 2020

Product: SB11 (biosimilar, ranibizumab)

  • EMA has accepted to review the MAA 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 biosimilar candidates: SB11 (ranibizumab) and SB15 (aflibercept) in the US, Canada, Europe, Japan, and Australia
  • Ranibizumab is an anti-VEGF (vascular endothelial growth factor) for retinal vascular disorders, which are a leading cause of blindness

4. Innovent and Lilly’s Halpryza (biosimilar, rituximab) Received NMPA’s Approval in China

Published: Oct 12, 2020

Product: Halpryza (biosimilar, rituximab)

  • NMPA has approved Halpryza for patients with DLBCL, FL, and CLL in China. The biosimilar is the fourth mAb approved in China following the approval of Tyvyt (biosimilar, sintilimab), Byvasda (biosimilar, bevacizumab) and Sulinno (biosimilar, adalimumab)
  • The clinical efficacy and safety of rituximab in CD20 +ve NHL have been confirmed in multiple large-scale clinical trials. Rituximab has received its FDA’s approval in 1997 for NHL, CLL, RA, GPA, MPA and PV
  • The approval of Halpryza will bring a new option to Chinese Lymphoma patients, help them to improve QoL & prolong their survival. Halprryza is rituximab injection and a recombinant human/murine chimeric mAb targeting CD20 antigen on the surface of B lymphocytes and mediates CDC and ADCC

5. Henlius Signed a License Agreement with Essex to Co-develop HLX04 (biosimilar, bevacizumab) for Ophthalmic Diseases

Published: Oct 19, 2020

Product: HLX04 (biosimilar, bevacizumab)

  • 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 filings and commercialization of HLX04 globally and will be responsible for 80% of all costs and expenses concerning the development of HLX04. Additionally, Essex has a right to grant a sublicense to third parties, for which Henlius will receive 20% of the related sublicensing revenue
  • Henlius is developing HLX04 for ophthalmic diseases, wAMD & DR. Henlius and Essex plan to conduct global clinical trials of HLX04 in China, Australia, EU & the US, & will apply MAA in different countries across the globe

6. NeuClone Reported Positive Results of NeuLara (biosimilar, ustekinumab) in P-l Study for Autoimmune Diseases

Published: Oct 21, 2020

Product: NeuLara (biosimilar, ustekinumab)

  • 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, CI (90%) of the GMR within the pre-specified (80%-125%) acceptance limits for all 3 pairwise comparisons. Additionally, the safety, immunogenicity and tolerability profiles were similar in all three treatment arms
  • NeuLara is a biosimilar referencing Stelara, being developed to treat patients with PsO, PsA, CD and UC. The biosimilar is being co-developed by NeuClone and its strategic manufacturing partner, Serum Institute of India

7. Samsung Bioepis Reported Results of Renflexis (biosimilar, infliximab) from Two Studies in IBD Patients

Published: Oct 27, 2020

Product: Renflexis (biosimilar, infliximab)

  • 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 demonstrated an 83% continuation rate over 1yr. with similar continuation rate in patients who underwent a single & double switch from reference infliximab
  • The second study focused on the real-world utilization pattern of infliximab products for IBD, within the context of VANF policy. The study found that Renflexis became the preferred infliximab product on VANF in Sept’2018 which was faster than the adoption of the previous biosimilar (infliximab-dyyb), listed on VANF in May’2017

8. SomaLogic Collaborated with the US FDA to Advance Biosimilar Development

Published: Oct 29, 2020

Product: Biosimilar

  • SomaLogic collaborate with the FDA to identify circulating pharmacodynamic biomarkers and analytical approaches that could be used to demonstrate bio-similarity of a biosimilar to a reference FDA-approved biologic drug
  • The collaboration will utilize the SomaLogic proteomic technology for the identification of circulating pharmacodynamic biomarkers for therapeutic biologics
  • SomaLogic’s SomaScan platform makes 5,000 protein measurements simultaneously in small samples of blood, to compare changes in circulating proteins following treatment with FDA-approved biologics and could reduce the need for costly and lengthy comparative clinical studies

9. Henlius Presented Results of HLX03 (biosimilar, adalimumab) in P-lll Study for Plaque Psoriasis at EADV 2020

Published: Oct 29, 2020

Product: HLX03 (biosimilar, adalimumab)

  • The P-III HLX03-Ps03 study involves comparing the efficacy, safety, and immunogenicity assessing of HLX03 (80mg, qd) with reference adalimumab in 262 Chinese patients in the ratio of (1:1) with moderate to severe plaque psoriasis
  • Result: On 1EPs % improvement of PASIwk16 (83.48% vs 82.02%), least-square mean difference (1.46%), no significant differences between the treatment groups in 2EPs that include PASI 75, PGA reaching clearance, and change in DLQI
  • HLX03 is an adalimumab biosimilar to be used for the treatment of autoimmune diseases including psoriasis, RA & AS

Related Post: Insights+ Key Biosimilars Events of September 2020

The post Insights+ Key Biosimilars Events of October 2020 first appeared on PharmaShots.

Insights+ Key Biosimilars Events of September 2020

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 product to biologics” possessing similar therapeutic properties. The month is flooded with biosimilar news where Henlius is on top as it unveils multiple news including NDA acceptance of HLX04 (biosimilar, bevacizumab), its presentation at CSCO, and an agreement with Accord for HLX02 (biosimilar, trastuzumab) in the US and Canada. Our team at PharmaShots has summarized 14 key events of the biosimilar space of Sept 2020.

Neuclone Disclosed Two Biosimilars Referencing Opdivo (nivolumab) and Keytruda (pembrolizumab)

Published: Sept 01, 2020

Products: Biosimilars

  • The company discloses two additional biosimilars in active development referencing Opdivo (nivolumab) and Keytruda (pembrolizumab). The biosimilars are in the advanced stages of pre-clinical development and are being co-developed by NeuClone and Serum Institute of India
  • The disclosure demonstrates NeuClone’s ability to develop multiple biosimilars simultaneously through its NeuMAX platform
  • Additionally, NeuClone and Serum Institute are developing eight other biosimilars including clinical-stage candidates referencing Stelara (ustekinumab) and Herceptin (trastuzumab)

Bio-Thera Initiated P-I Study of BAT2206 Proposed Biosimilar to Stelara (ustekinumab)

Published: Sept 04, 2020

Products: BAT2206

  • The first patient has been dosed in a P-I clinical study to compare the PK and safety of BAT2206, a proposed biosimilar to Stelara (ustekinumab) to US/EU-sourced reference product in healthy volunteers
  • The company is expected to enroll 270 healthy volunteers. BAT2206 represents the fifth biosimilar of Bio-Thera’s portfolio that has advanced into clinical development
  • BioThera is developing additional products, including QLETLI (biosimilar to Humira), which is approved in China, BAT1706 (biosimilar to Avastin), that has completed a P-III study with expected regulatory submission in Q4’20. The company is also pursuing biosimilar versions of Actemra, Cosentyx, and Simponi

Innovent’s Sulinno (biosimilar, adalimumab) Received NMPA’s Approval for Autoimmune Diseases

Published: Sept 04, 2020

Products: Sulinno (biosimilar, adalimumab)

  • The NMPA has approved Sulinno for the treatment of RA, AS, and psoriasis in China. The approval of the Sulinno marks the expansion of Innovent’s portfolio in the non-oncology field
  • Sulinno has similar clinical efficacy and safety to its reference product, Humira. The launch will provide Chinese patients with affordable adalimumab, bringing hope and opportunities to more patients
  • Sulinno is a biosimilar referencing Humira and is the third mAb approved by NMPA following the approval of Tyvyt (sintilimab) and Byvasda (bevacizumab)

Henlius Reported NMPA’s Acceptance of NDA for HLX04 (biosimilar, bevacizumab)

Published: Sept 11, 2020

Products: HLX04 (biosimilar, bevacizumab)

  • NMPA has accepted the NDA of HLX04, based on the series of study data, including comparative pharmaceutical quality studies, comparative non-clinical studies & clinical studies. The NDA acceptance makes HLX04 the fourth product of Henlius that has received NMPA’s NDA acceptance & can be potentially used for the treatment of advanced/ metastatic or recurrent NSCLC and metastatic colorectal cancer
  • The P-III study assessing the efficacy, safety, and immunogenicity of HLX04 or the reference bevacizumab + oxaliplatin and fluoropyrimidine-based CT (XELOX or mFOLFOX6) as a 1L treatment in Chinese patients with metastatic colorectal cancer
  • The study met its 1EPs of PFS @36wks.and has shown similarity to the reference product in terms of efficacy, safety, and immunogenicity. Additionally, Henlius is evaluating the HLX04 in combination with HLX10 for the treatment of solid tumors and is the first dual mAb combo therapy that has received IND approval

Merck’s Brenzys (biosimilar, etanercept) Received Health Canada Approval for Multiple Indications

Published: Sept 16, 2020

Products: Brenzys (etanercept, biosimilar)

  • Health Canada has approved Brenzys for new indications that include adults & pediatric patients (4-17yrs.) with PsO who are candidates for systemic therapy/ phototherapy, adult patients with PsA, and patients aged 4-17yrs. with JIA
  • The clinical efficacy and safety studies conducted in patients with RA demonstrate clinical comparability between Brenzys and the reference product. The extrapolation of these data supports the use of Brenzys in AS
  • Brenzys is a biosimilar referencing Enbrel, which is approved for use for PsO, PsA, and JIA in Canada. Brenzys received its first Health Canada approval in 2016 for the mod. to sev. RA in adults and AS and is administered via injection under the skin and should be used under the guidance and supervision of a physician

Henlius Present P-III Data of HLX02 (biosimilar, trastuzumab) at ESMO

Published: Sept 17, 2020

Products: HLX02 (biosimilar, trastuzumab)

  • The P-III HLX02-BC01 study involves assessing HLX02 vs EU-sourced trastuzumab in combination with docetaxel in a 3wks. cycle for up to 1yr. in patients in a ratio (1:1) with HER2-positive recurrent/ mBC, prior not treated with systemic treatment 
  • Results:  Per ITT set, ORRwk24 (71.3% vs 71.4%); Per PP set, ORRwk24 (74.2% vs 73.2%); All subgroup analyses showed no statistically significant differences in ORR between the treatment groups in all populations, demonstrating the equivalence in efficacy
  • No difference between the two treatment groups in 2EPs, including CBR, DCR, DoR, PFS, and OS

Samsung Bioepis Presented P-III Exploratory Analyses Results of Aybintio (biosimilar, bevacizumab) at ESMO 2020

Published: Sept 17, 2020

Products: Aybintio (biosimilar, bevacizumab)

  • The exploratory analyses of the P-III study evaluate the equivalent efficacy of Aybintio vs reference bevacizumab in combination with paclitaxel & carboplatin, q3w up to 6 cycles followed by Aybintio or reference bevacizumab as maintenance monothx. in 665 patients with metastatic/recurrent nsq. NSCLC
  • Results: previous analysis demonstrate ORR in PPS (50.1% vs 44.8%); expanded analysis showed the risk difference in best ORR by 11 & 17wks. (2.2% vs 2.4%); mean of maximum % change from baseline in tumor burden @24wks. (-27.8% vs -27.3%)
  • Aybintio is a biosimilar referencing Avastin and has received EC’s approval in Aug’2020 for mCRC, mBC, NSCLC, mRCC, epithelial ovarian, fallopian tube, primary peritoneal cancer and cervical cancer

Lotus Signed an Exclusive Commercialization Agreement with CKD for Biosimilar Darbepoetin Alfa

Published: Sept 18, 2020

Products: Biosimilar Darbepoetin Alfa

  • Lotus to get an exclusive commercialization right of biosimilar Darbepoetin alfa in Taiwan and Southeast Asian markets
  • The collaboration allows the Lotus to re-emphasize its focus on nephrology as a core therapy in key Asian markets by ensuring the access to quality medication and maintains growth momentum with another addition to its biosimilar pipeline
  • Darbepoetin alfa from CKD is the 5th biosimilar product Lotus has in the pipeline. Lotus has the rights to commercialize bevacizumab and adalimumab in multiple Asian countries and has submitted MAA for trastuzumab in Korea, and teriparatide in both Taiwan and Thailand

Henlius Presented P-III Data of HLX04 (biosimilar, bevacizumab) at CSCO 2020

Published: Sept 20, 2020

Products: HLX04 (biosimilar, bevacizumab)

  • The P-III HLX04-mCRC03 study involve assessing of HLX04 (7.5mg/kg, q3w, when combined with XELOX or 5mg/kg, q2w when combined with mFOLFOX6) vs reference bevacizumab + CT (XELOX or mFOLFOX6) as a 1L treatment in 675 patients in a ratio (1:1) with mCRC
  • Results: PFSR36wk (46.4% vs 50.7%); no difference in 2EPs including OS, PFS, ORR, TTR, and DoR
  • HLX04 is a bevacizumab biosimilar, indicated for advanced, metastatic, or recurrent NSCLC and metastatic colorectal cancer. Additionally, NMPA has accepted NDA of HLX04

Henlius Reported First Patient Dosing with HLX11 (biosimilar, pertuzumab) for HER2-Positive Metastatic Breast Cancer and Early Breast Cancer

Published: Sept 20, 2020

Products: HLX11 (biosimilar, pertuzumab)

  • The company has reported the first patient dosing in P-l study assessing the safety, tolerability, and immunogenicity of HLX11 vs US-, EU- and China-sourced reference pertuzumab in healthy Chinese male
  • The 1EPs of the study is to compare the PK b/w HLX11 and the three different sourced reference drugs head-to-head while the 2EPs is to evaluate the safety, tolerability, and immunogenicity of HLX11 and the reference drug, further describing the PK profile
  • HLX11 can be potentially used for the treatment of HER2-positive mBC & eBC. Additionally, the study demonstrated that combining pertuzumab with trastuzumab and CT can decrease the risk of recurrence or death for HER2+ BC

Alvotech and DKSH Extended their Collaboration to Commercialize Six Biosimilars in Asia  

Published: Sept 22, 2020

Products: AVT02 (biosimilar, adalimumab).

  • It is also an expansion of their strategic partnership to commercialize six new biosimilar product candidates for the Asian markets
  • In Mar’2020, the companies collaborated for AVT02 (biosimilar, adalimumab). The collaboration targets Taiwan, Korea, Hong Kong, Philippines, Vietnam, Thailand, Cambodia, Myanmar, Malaysia, Singapore, Indonesia, India, Bangladesh, and Pakistan
  • The expansion deepens the partnership b/w the two companies to accelerate the introduction of high quality biosimilar to patients in Asia

Accord Launched Zercepac (biosimilar, trastuzumab) in the UK

Published: Sept 25, 2020

Products: Zercepac (biosimilar, trastuzumab)

  • Accord launches Zercepac as s a biosimilar referencing Herceptin in the UK, following the EC’s approval in Jul’2020.
  • The EC’s approval is based on a series of robust studies including comparative quality studies, pre/ clinical studies. The results confirmed the Zercepac’s bio-similarity, demonstrating comparable efficacy and safety to the Herceptin
  • Zercepac is the first mAb and the fourth biosimilar launched in the EU and is indicated for patients with HER2+ eBC, HER2+ mBC and previously untreated HER2+ metastatic gastric cancer and will be available in a 150mg single-dose vial

Innovent Reported Results of Dual Regimen in P-III ORIENT-32 Study as 1L Therapy for Advanced HCC

Published: Sept 28, 2020

Products: Tyvyt (sintilimab) + Byvasda (biosimilar, bevacizumab)

  • The P-III ORIENT-32 involves assessing of Tyvyt (sintilimab) + Byvasda (bevacizumab, biosimilar) vs sorafenib in a ratio (2:1) for 1L treatment of patients with advanced HCC
  • The study resulted in meeting its 1EPs of PFS and OS, the safety profile is consistent with prior studies, and no new safety signals were identified. Following the IDMC recommendation, Innovent to review the results with NMPA’s CDE in China
  • Tyvyt is a type of IgG4 mAb, that binds to PD-1 molecules on the surface of T-cells, blocking the PD-1 pathway and reactivates T-cells to kill cancer cells. The company is evaluating Tyvyt in 20+ studies across multiple cancer indications globally

Henlius Signed an Exclusive License Agreement with Accord for HLX02 (biosimilar, trastuzumab) in the US and Canada

Published: Sept 30, 2020

Products: HLX02 (biosimilar, trastuzumab)

  • 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 develop and commercialize HLX02 in the US & Canada. The development process strictly followed the EMA and NMPA’s biosimilar guidelines
  • In 2018, the companies enter into a license agreement, under which Henlius granted Accord UK exclusive commercialization rights of HLX02 in the EU, the Middle East, North Africa, and the Commonwealth of Independent States. The therapy received EC’s and the NMPA approval sin July & Aug’2020, making it the first China-developed mAb biosimilar approved both in China and in the EU

Related News: Insights+ Key Biosimilars Events of August 2020

The post Insights+ Key Biosimilars Events of September 2020 first appeared on PharmaShots.

Insights+ Key Biosimilars Events of July 2020

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 product to biologics” possessing similar therapeutic properties. Mylan with its partner Kyowa Kirin received the US FDA’s approval for its adalimumab biosimilar, Hulio (adalimumab-fkjp). Cadila expanded its footprints in India with the launch of its two biosimilars Bevaro (bevacizumab, biosimilar) and Ritucad (rituximab, biosimilar). Our team at PharmaShots has summarized 9 key events of the biosimilar space of July 2020.

1. Samsung Bioepis Reported the Initiation of P-III Study for SB15 Proposed Biosimilar to Eylea (aflibercept)

Date: Jul 01, 2020  

Product: SB15 Biosimilar

  • The P-III study compared the efficacy, safety, PK, and immunogenicity between SB15 and Eylea in 446 patients with neovascular age-related macular degeneration
  • The company has two ophthalmology biosimilar candidates in clinical development, SB11 (ranibizumab) and SB15 (aflibercept). On May 18, 2020, Samsung Bioepis reported 24-week interim results from a P-III study of SB11 (proposed ranibizumab biosimilar)
  • SB15 is a proposed biosimilar referencing Regeneron’s Eylea, currently under preclinical treatment for diabetic macular edema, diabetic retinopathy, retinal edema, and retinal vein occlusion

2. Mylan and Fujifilm Kyowa Kirin Received the US FDA’s Approval for its Hulio (biosimilar, adalimumab)

Date: Jul 09, 2020

Product: Hulio (adalimumab-fkjp)

  • The US FDA has approved Hulio (adalimumab-fkjp), a biosimilar to AbbVie’s Humira (adalimumab) to treat RA, JIA (in patients aged ≥4yrs.), PsA, AS, adult CD,  UC, and PsO, in both prefilled syringe and auto-injector presentations
  • The approval was based on an analytical, pre/ clinical program. The P-III ARABESC study conducted by Fujifilm Kyowa Kirin, demonstrated no differences in terms of safety, efficacy, and immunogenicity compared to its reference product in patients with RA
  • In 2018, the companies collaborated to commercialize Hulio in the EU while expanded the agreement globally in 2019. As per the patent license agreement with AbbVie, Mylan will be able to launch Hulio in the US in Jul’2023

3. Bio-Thera Signed a License Agreement with Pharmapark for BAT2506 (golimumab, biosimilar)

Date: Jul 17, 2020  

Product: BAT2506 (golimumab, biosimilar)

  • Bio-Thera will take care of full development, and commercial supply of BAT2506 out of the manufacturing facilities in Guangzhou, China. Additionally, the agreement will utilize Pharmapark’s local presence, sales, and marketing capabilities in Russia and other CIS countries
  • Pharmapark to get exclusive rights to distribute and market the product in Russia and other CIS countries including its filing practices. In Q4’20, Bio-Thera to begin its global P-III trial in PsA patients and will include patients from China, Russia, and many other countries 
  • Bio-Thera’s BAT2506 is a mAb while the company plans for regulatory submission with NMPA, EMA and the US FDA in 2023

4. Cadila to Launch its Bevaro (bevacizumab, biosimilar) in India

Date: Jul 22, 2020  

Product: Bevaro (bevacizumab, biosimilar)

  • Cadila plans to launch multiple biosimilars including Bevaro in 2020 which are safe and efficacious compared to conventional treatment therapies
  • The company has also cleared he USFDA inspection in Feb’20 and holds approved 16 ANDAs plus currently filed 30 ANDAs  
  • Bevaro is a mAb will be available in two strengths of 100 and 400 mg targeted for Ovarian Cancer, Glioblastoma Multiforme (a type of Brain cancer), Colorectal Cancer, Breast Cancer, Lung Cancer, Cervical Cancer and Kidney Cancer in India

5. Centus Biotherapeutics’ Equidacent (bevacizumab, biosimilar) Received CHMP’s Positive Opinion for the Treatment of Multiple Cancer Indications

Date: Jul 27, 2020

Product: Equidacent (bevacizumab, biosimilar)

  • The EMA’s CHMP has adopted a positive opinion that recommended 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 solution for infusion targeting VEGF and act by inhibiting the binding of VEGF to its receptors on endothelial cell
  • The company anticipates EC’s decision in ~60days. The clinical data demonstrated that Equidacent has comparable quality, safety, and efficacy to Avastin

6. NCCN Collaborated with Pfizer to Explore Adoption of Biosimilars in Oncology

Date: Jul 27, 2020

Products: Biosimilars

  • NCCN and Pfizer issued an open RFP that can 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 centres, patient advocacy groups, and HCPs organizations in the US and are due on Sept 09, 2020
  • The NCCN ORP will boost up the discovery that improves the lives of people with cancer and supports preclinical, translational, clinical research and quality improvement projects in oncology

7. Celltrion’s Remsima SC (infliximab, CT-P13) Received the EC’s MAA for Additional Five Indications

Date: Jul 27, 2020  

Product: Remsima SC (infliximab, CT-P13)

  • The approval followed the EMA’s CHMP positive opinion based on a study assessing Remsima SC (120 mg) vs IV formulations in patients with Crohn’s disease and ulcerative colitis, evaluating its PK, efficacy, and safety
  • The study resulted in high efficacy and safety comparable with IV formulation and the SC administration will also reduce the treatment time to approximately 2-5 minutes
  • Remsima is a world’s first mAb indicated to treat eight autoimmune diseases including RA & IBD and approved in the US & EU with Inflectra & Remsima respectively. Till now the product is approved in 94 countries including the US, Canada, Japan and throughout EU

8. Cadila to Launch its Ritucad (rituximab, biosimilar) in India

Date: Jul 27, 2020  

Product: Ritucad (rituximab, biosimilar)

  • Cadila to strengthen its biosimilar portfolio and oncology footprints in India with the launch of Ritucad and has cleared USFDA inspection in Feb’20
  • Additionally, the company has launched its Bevaro (bevasizumab, biosimilar) a mAb targeted for multiple cancer indications like Ovarian Cancer, Glioblastoma Multiforme, Colorectal Cancer, Breast Cancer, Lung Cancer, Cervical Cancer and Kidney Cancer in India
  • Ritucad is the second biosimilar in Cadila’s portfolio of biosimilars and will be available in a single-dose vial of two strengths, 100 mg & 500mg targeted to treat Non-Hodgkin’s lymphoma and RA

9. Henlius and Accord’s Zercepac (trastuzumab, biosimilar) Received the EMA Approval for HER2-Positive Breast Cancer and Gastric Cancer

Date: Jul 30, 2020

Product: Zercepac (trastuzumab, biosimilar)

  • The approval was 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 a global multi-centre P-III clinical study
  • Zercepac is a novel China-mAb approved in the EU for the treatment of HER2+ early breast cancer, HER2+ metastatic breast cancer, and HER2+ metastatic gastric cancer with an expected launch in China in 2020 while its manufacturing site has received EU GMP certificates

Related Post: Insights+ Key Biosimilars Events of June 2020




Henlius and Accord’s Zercepac (trastuzumab, biosimilar) Receive the EMA Approval for HER2-Positive Breast Cancer and Gastric Cancer

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 a global multi-center P-III clinical study
  • Zercepac is a novel China-mAb approved in the EU for the treatment of HER2+ early breast cancer, HER2+ metastatic breast cancer, and HER2+ metastatic gastric cancer with an expected launch in China in 2020 while its manufacturing site has received EU GMP certificates

Click here to read full press release/ article | Ref: Henlius | Image: Behance