Biosimilar Development News

  1. Mundipharma Enters Partnership With Samsung Bioepis To Expand Biosimilars Into Hong Kong And Taiwan 1/12/2020

    Mundipharma today announced a partnership with Samsung Bioepis to commercialize Samsung Bioepis' first-wave biosimilar candidates in Taiwan and Hong Kong.

  2. Samsung Bioepis And AffaMed Therapeutics’ Eculizumab Biosimilar Candidate Receives China IND Approval, Expanding The Ongoing Global Phase 3 Trial 1/9/2020

    Samsung Bioepis Co., Ltd. and AffaMed Therapeutics today announced that the China National Medical Products Administration (NMPA) has approved the Clinical Trial Application (CTA) for SB12, also referred to as AMT904 in China – a biosimilar candidate referencing Soliris® (eculizumab).

  3. Sorrento Announces Filing For Approval Of Infliximab Biobetter Antibody By Its Partner Mabpharm In China 1/6/2020

    Sorrento Therapeutics (Nasdaq: SRNE) announced today that its partner Mabpharm (HK:2181) filed recently a New Drug Application for the Infliximab biosimilar antibody in China. Sorrento plans to file a Biologics License Application (BLA) for the Infliximab biobetter antibody in the United States in 2020.

  4. Novo Nordisk’s New Insulin Affordability Offerings Now Available In The US 1/2/2020

    Today, Novo Nordisk launched the My$99Insulin Program, follow-on brands of insulins, and an Immediate Supply option, expanding its insulin affordability offering to help people with diabetes who need alternative solutions.

  5. PharmaForce International: Unique Sales Force Trends In The EU5 Biosimilar Market 12/24/2019

    PharmaForce International recently released two separate reports that focus on the benchmarking of biosimilar sales and marketing organizations in France, Germany, Italy, Spain, and the United Kingdom.

  6. Amgen And Allergan Submit Biologics License Application For ABP 798, Biosimilar Candidate To Rituxan® (rituximab), To U.S. Food And Drug Administration 12/19/2019

    Amgen (NASDAQ:AMGN) and Allergan plc. (NYSE:AGN) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ABP 798, a biosimilar candidate to Rituxan® (rituximab).

  7. Daiichi Sankyo Launches Antitumor Agent Bevacizumab Biosimilar For Intravenous Drip Infusions ‘Daiichi Sankyo’ In Japan 12/19/2019

    Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced that it has launched the antitumor agent bevacizumab BS for intravenous drip infusions 100 mg and 400 mg “Daiichi Sankyo” (generic name: bevacizumab (genetical recombination) [bevacizumab biosimilar 2], hereafter, “the product”) today in Japan.

  8. WHO Prequalifies First Biosimilar Medicine To Increase Worldwide Access To Life-Saving Breast Cancer Treatment 12/18/2019

    Today the World Health Organization (WHO) prequalified its first biosimilar medicine – trastuzumab – in a move that could make this expensive, life-saving treatment more affordable and available to women globally.

  9. Statement On Low-Cost Biosimilar And Interchangeable Protein Products 12/17/2019

    Ensuring an efficient pathway to bring potentially lower-cost biosimilar and interchangeable protein products to market is key for expanding access to these products and increasing competition, ultimately helping American patients.

  10. Alberta Becomes Second Province To Implement Biosimilar Switching Initiative 12/12/2019

    Biosimilars Canada, a national association representing Canada’s biosimilar medicines industry, today congratulated the Government of Alberta for becoming the second province in Canada to implement a biosimilar “switching” or transitioning program.