Biosimilar Development News

  1. Polpharma Biologics Group Announces That Its Joint Venture Company, Bioeq, Has Entered Into A Commercialization Agreement For Biosimilar Ranibizumab 7/7/2021

    Polpharma Biologics Group announces that its joint venture company with Santo Holding (Strüngmann Group), Bioeq, has concluded a commercial partnership with Teva Pharmaceutical Industries Ltd. for their biosimilar candidate of the ophthalmological drug Ranibizumab (Lucentis) in Europe, Canada, Israel and New Zealand.

  2. Alvotech Initiates Clinical Studies For AVT04, A Proposed Biosimilar To Stelara (Ustekinumab) 7/6/2021

    Alvotech, the Iceland-based biosimilar company, today announced that the first patient has been dosed in the comparative, confirmatory efficacy and safety clinical study (AVT04-GL-301) for AVT04, Alvotech‘s proposed biosimilar to the reference product Stelara.

  3. Biosimilars Canada Welcomes The Implementation Of Quebec’s Biosimilar Policy 7/5/2021

    Biosimilars Canada today welcomed the release of the details of the Government of Quebec’s biosimilar switching policy, which will increase the use of biosimilar medicines under the Public Prescription Drug Insurance Plan and generate significant savings for the province.

  4. New Data On Phase 1 Proposed Biosimilar Gan & Lee Insulins Aspart (GL-ASP), Lispro (GL-LIS), And Glargine (GL-GLA) Presented At The American Diabetes Association's 81st Scientific Sessions 7/2/2021

    Gan & Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as Gan & Lee, stock code: 603087.SH), announced positive Phase 1 clinical trial results at the 81st Scientific Sessions of the American Diabetes Association (ADA), June 25th – 29th.

  5. Biosimilars Forum Member Spotlight: 6 Questions For Coherus 6/30/2021

    The Biosimilars Forum is comprised of companies with the most significant U.S. biosimilars development portfolios. Today, we’re highlighting Coherus. The Forum spoke with Coherus’ CEO Dennis Lanfear about Coherus and its work in the biosimilars landscape.

  6. New Paper Explores How Biosimilars Expand Cancer Treatment Options 6/29/2021

    A new paper from the Alliance for Patient Access (AfPA), a national nonprofit patient advocacy organization, explores how biosimilars offer more treatment options for people living with cancer. Authored by oncologists Arturo Loaiza-Bonilla, MD, and Jeffrey VanDeusen, MD, PhD, the paper calls for robust data to boost physician confidence as well as the autonomy to make personalized treatment decisions.

  7. Teva And Bioeq Announce Commercial Partnership For Biosimilar 6/28/2021

    Teva Pharmaceutical Industries Ltd. and Bioeq AG ("Bioeq") today announced that they have entered into a strategic partnership for the exclusive commercialization of Bioeq's FYB201, a biosimilar candidate to Lucentis (ranibizumab) in Europe, Canada, Israel and New Zealand

  8. Innovent Announces The China NMPA Approval Of TYVYT® (Sintilimab Injection) In Combination With BYVASDA® (Bevacizumab Biosimilar Injection) As First-Line Therapy For People With Hepatocellular Carcinoma 6/27/2021

    Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases today announced that the National Medical Products Administration (NMPA) of China has approved the supplemental New Drug Application (sNDA) for TYVYT® (sintilimab injection) in combination with BYVASDA® (bevacizumab biosimilar injection) as a first-line treatment for people with advanced or unresectable hepatocellular carcinoma (HCC). This is the first regulatory approval of a PD-1 inhibitor-based combination therapy for the first-line treatment for HCC.

  9. Samsung Bioepis And Biogen Receive Positive CHMP Opinion For Ranibizumab Biosimilar, BYOOVIZ™ 6/25/2021

    Samsung Bioepis Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for BYOOVIZ™, a biosimilar candidate referencing Lucentis®1 (ranibizumab), also known as SB11.

  10. Alvotech Bondholders Convert More Than $100M At Pre-Money Valuation Of $2.7B 6/25/2021

    Alvotech Holdings SA today announced that it has entered into an amendment and restatement agreement with bondholders of its $300M covertible bond issued on December 14, 2018.