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.
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
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
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
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
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
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
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