Get more biosimilar development insight with our FREE newsletter sign me up
Biosimilar Development News Documents on Biosimilar Development
Sign in or Sign-up

Biosimilar Development News

  1. Samsung Bioepis Enters Into Commercialization Agreement For Next-Generation Biosimilar Candidates 11/6/2019

    Samsung Bioepis Co., Ltd. announced recently that it has entered into a new commercialization agreement with Biogen (Nasdaq: BIIB) for two biosimilar candidates under development by Samsung Bioepis, SB11(ranibizumab) and SB15 (aflibercept), in the United States (US), Canada, Europe, Japan, and Australia. SB11, a biosimilar candidate referencing LUCENTIS (ranibizumab), is undergoing phase 3 clinical trial, while SB15, a biosimilar candidate referencing EYLEA (aflibercept), is in pre-clinical development.

  2. Biogen To Expand Biosimilars Portfolio And Gain Access To Additional Markets Through New Transaction With Samsung Bioepis 11/6/2019

    Biogen Inc. (Nasdaq: BIIB) today announced a new proposed transaction with Samsung Bioepis Co., Ltd. to secure the exclusive rights to commercialize two new ophthalmology biosimilars, SB11 referencing Lucentis® and SB15 referencing Eylea®, in major markets worldwide, including the U.S., Canada, Europe, Japan and Australia.

  3. New White Paper To Detail European Biosimilar Evolution And Policy Principles 11/6/2019

    The Alliance for Safe Biologic Medicines (ASBM) today released an abstract from a forthcoming white paper that provides a comprehensive overview of the evolution of the European biosimilars market.

  4. Henlius HLX01 (Rituximab Injection) Wins ‘Biosimilar Initiative Of The Year’ At Global Generics & Biosimilars Awards 2019 11/6/2019

    Shanghai Henlius Biotech, Inc. (2696.HK), a leading biopharmaceutical company in China focusing on oncology and autoimmune diseases, won the award of "Biosimilar Initiative of the Year" (HLX01, rituximab injection) and was also shortlisted for the award of "the Company of the Year, Asia-Pacific" at the 6th Global Generics & Biosimilars Awards 2019 ceremony held on 5 November 2019 in Frankfurt, Germany, which makes Henlius the first Chinese enterprise to clinch the award.

  5. Bioeq Announces Coherus As Marketing And Distribution Partner For Its Biosimilar To Lucentis® (Ranibizumab) In The U.S. 11/6/2019

    Bioeq IP AG ("Bioeq") today announced that it signed a license and development agreement with Coherus BioSciences, Inc. ("Coherus"Nasdaq:CHRS), under which Coherus will exclusively market and distribute Bioeq's biosimilar candidate to Lucentis® (ranibizumab) in the United States (U.S.)

  6. Sandoz receives US FDA approval for long-acting oncology supportive care biosimilar Ziextenzo™ (pegfilgrastim-bmez) 11/5/2019

    andoz, a Novartis division and a global leader in biosimilars, today announced that the US Food and Drug Administration (FDA) approved its biosimilar ZiextenzoTM (pegfilgrastim-bmez). Sandoz biosimilar pegfilgrastim has been approved and marketed in Europe as Ziextenzo® (pegfilgrastim) since 2018.  Sandoz now intends to launch Ziextenzo in the US as soon as possible this year.

  7. Biocon's Biologics Drug Products Facility In Bengaluru Receives EIR From U.S. FDA 11/5/2019

    Biocon Ltd, an innovation-led global biopharmaceuticals company, recently announced that it has received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA) for its Biologics Drug Product facility in Bengaluru, stating the inspection is closed. This reaffirms Biocon Biologics’ global scale manufacturing capability for high quality, affordable biosimilars for the U.S. market.

  8. Research Brief: Biosimilar Drugs Can Reduce Costs But Still Face Challenges In The U.S. 11/4/2019

    Biologics used to treat patients can be incredibly expensive, so there was significant hope that biosimilar drugs — which are highly similar to an existing biologic drug on the market — could serve as a less-costly substitute.

  9. Yas Holding Invests In Alvotech And Agrees On A Strategic Partnership For Biosimilar Candidates 11/4/2019

    Biopharmaceutical company Alvotech announced recently that Abu Dhabi-based investment company, Yas Holding, has acquired a 2.5% stake in their business and signed an agreement for the exclusive partnership and supply of three Alvotech biosimilar candidates, which Yas Holding will commercialize in the MENA region.

  10. Ascentage Pharma And Henlius Form A Combination Therapy Strategic Collaboration 11/4/2019

    Ascentage Pharma (6855.HK), a globally-focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, hepatitis B virus and age-related diseases, today announced a combination therapy strategic collaboration with Henlius (2696.HK), working together to conduct clinical trials of the combination therapy between APG-2575, a novel, orally administered Bcl-2 selective inhibitor developed by Ascentage Pharma, and HLX01 (Rituximab Injection), the first launched product by Henlius, for the treatment of chronic lymphocytic leukemia (CLL) in the People's Republic of China.