Insights+ Key Biosimilars Events of April 2021

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Insights+ Key Biosimilars Events of April 2021

  • 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 April, Biocon and Viatris received EC's approval for Abevmy while Valeo launched LMHW biosimilar in Canada. Our team at PharmaShots has summarized 11 key events of the biosimilar space of April 2021

mAbxience's MB02 (biosimilar, bevacizumab) Received EC's Approval for the Treatment of Cancer

Published: Apr 05, 2021

Product: MB02 (biosimilar, bevacizumab)

  • 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 to Avastin (bevacizumab)
  • The launch of Bevacizumab has provided high quality, affordable medicine and opportunity to the healthcare system and improve patient access to biological treatments throughout the EU

Xcenda's FormularyDecisions Launched Resource Hub for Biosimilars

Published: Apr 08, 2021

Product: Biosimilar

  • FormularyDecisions new feature will provide registered users with centralized access to pertinent product and drug pipeline information, regulatory guidance and state-specific substitution laws
  • The biosimilar hub will provide users an interactive chart of the US biosimilar market landscape, curated biosimilar resources and dynamic repository of state substitution laws for biosimilar products
  • With the hub, the company is providing the payers with information at all stages of the product lifecycle in an easily accessible format, ultimately helping to enhance the formulary decision-making process

British Columbia Added Humira Adalimumab to Biosimilar Switching Program

Published: Apr 09, 2021

Product: Biosimilar

  • British Columbia and Health Minister Adrian Dix expand the biosimilar switching program to include Humira adalimumab and a new indication for Enbrel etanercept
  • The expansion of the biosimilar switching program demonstrated the province's continued confidence in biosimilars to manage costs and fund innovative new therapies while supporting positive patient outcomes
  • BC continues to apply its biosimilar switching policy as new indications become available for marketed biosimilars, and patients taking Enbrel etanercept for the treatment of plaque psoriasis will transition to an etanercept biosimilar during the same period

Biogen Signed a License and Commercialization Agreement with Bio-Thera for BAT1806 (biosimilar, tocilizumab) to Treat Moderate to Severe Rheumatoid Arthritis

Published: Apr 09, 2021

Product: BAT1806 (biosimilar, tocilizumab)

  • 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 expand its global biosimilars footprint with the potential approval of BAT1806 is a P-III clinical stage IL-6 receptor mAb that is a proposed biosimilar referencing Actemra (tocilizumab)

PlantForm Signed Research and Development Agreement with Bio-Manguinhos/Fiocruz to Develop Biosimilar Pembrolizumab

Published: Apr 09, 2021

Product: Biosimilar Pembrolizumab

  • 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 referencing Merck's Keytruda, which is used in immunotherapy to treat a variety of cancers including melanoma, lung cancer, head and neck cancer, and stomach cancer

Valeo Pharma Launched Redesca and Redesca HP (LMHW biosimilar) in Canada

Published: Apr 15, 2021

Product: Redesca and Redesca HP (LMHW biosimilar)

  • Valeo has started commercial shipment of Redesca and Redesca HP, its low molecular weight heparin ("LMWH") biosimilar across Canada
  • The LMWH is being used primarily for treating and preventing deep vein thrombosis and pulmonary embolism and is now increasingly used as a 1L of defense tool in the fight against COVID-19
  • Redesca is a low molecular weight heparin biosimilar

Prestige Biopharma and Pharmapark Signed an Exclusive License and Supply Agreement to Commercialize HD204 (biosimilar, bevacizumab) in Russia

Published: Apr 16, 2021

Product: HD204 (biosimilar, bevacizumab)

  • 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 P-III SAMSON-II trial that involves assessing the safety & efficacy of HD204 to the reference, Roche's Avastin for multiple cancer indications

Province Expanded the Use of Biosimilars to Improve the Sustainability of Public Drug Plans

Published: Apr 21, 2021

Product: Biosimilar

  • The provincial government is improving the sustainability of its public drug plans by expanding the use of biosimilars
  • This initiative follows similar policies implemented by British Columbia and Alberta over the past 2yrs., where 10,000 of patients in each province were safely switched from an originator biologic drug to a biosimilar
  • The initiative allows the government to fund new drugs as switching to biosimilar results in savings. The province's plans to provide subsidized drug coverage for about 135,000 people while in 2019-20, the province invested about $220M in these drug plans

New Brunswick Government Introduced Biosimilars Switch Policy to Improve Patient Access to Safe and Effective Medicine

Published: Apr 21, 2021

Product: Biosimilar

  • New Brunswick joins British Columbia and Alberta in implementing a 'switch' policy that changes coverage for specific biologic medicines
  • Patients switching from reference biologics to biosimilar versions will continue receiving safe, effective treatment and will enable to save millions of dollars once implemented
  • Sandoz is committed to supporting patients, their HCPs, and the New Brunswick Government with high quality biosimilar medicines and experienced, comprehensive patient support programs

Boehringer Ingelheim Reported Results of Cyltezo (biosimilar, adalimumab) in P-III VOLTAIRE-X Study for Moderate-to-Severe Chronic Plaque Psoriasis

 Published: Apr 23, 2021

Product: Cyltezo (biosimilar, adalimumab)

  • The P-III VOLTAIRE-X interchangeability study involves assessing the PK similarity, efficacy, immunogenicity, and safety profiles between patients with mod. to-sev. chronic PsO receiving Humira (40mg/0.8mL) continuously vs those who switched several times b/w Cyltezo and Humira
  • Results: @32wks. the study met its 1EPs, supporting Cyltezo's application as an interchangeable biosimilar to the reference product
  • The study showed that switching b/w Cyltezo (adalimumab-adbm) and Humira resulted in similar PK, efficacy, immunogenicity, and safety. The company has submitted sBLA for Cyltezo for designation as an interchangeable biosimilar to Humira with an anticipated PDUFA date in Q4'21

Biocon Biologics and Viatris Received European Commission Approval for Abevmy (biosimilar, bevacizumab)

Published: Apr 27, 2021

Product: Abevmy (biosimilar, bevacizumab)

  • 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, Liechtenstein, and Norway
  • The approval will strengthen Biocon's portfolio of biosimilars for cancer in the EU, which include biosimilar Trastuzumab and biosimilar Pegfilgrastim


Related Post:  Insights+ Key Biosimilars Events of March 2021

Senior Editor

This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com

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