Biosimilar Development News

  1. Biocon Features In The Prestigious ASIA IP ELITE List For The Fourth Consecutive Year

    Biocon Ltd, an innovation-led global biopharmaceuticals company, today announced that it has been recognised as the ASIA IP ELITE for the fourth year in a row and its wholly-owned subsidiary Biocon Biologics makes its debut on this prestigious list in 2019 by the IP Business Congress Asia (IPBC Asia) for robust Intellectual Property (IP) management and consistent IP value creation.

  2. Sandoz Presents Real-World Data Showing Effectiveness Of Erelzi® (etanercept-szzs) In Rheumatic Disease Treatment

    Sandoz, a Novartis division and a global leader in biosimilars, presented an interim analysis (abstract number 553) from the COMPACT study on real-world treatment of rheumatic disease patients with biosimilar Erelzi® (etanercept-szzs) at the 2019 American College of Rheumatology and Association of Rheumatology Professionals (ACR/ARP) Annual Meeting in Atlanta, Georgia.

  3. ICYMI: Trump Administration’s Joe Grogan Recognizes Need For Biosimilar Incentives To Help Lower Healthcare Costs

    Last Friday, White House Domestic Policy Council Director Joe Grogan spoke to reporters about domestic policy decision-making at the White House, and specifically called out the bipartisan progress on biosimilars.

  4. New Data Show Non-Inferiority Of Efficacy For Subcutaneous Formulation Of CT-P13 (Biosimilar Infliximab) To Intravenous Formulation Of CT-P13 In People With Rheumatoid Arthritis

    Celltrion Healthcare today announced data, at the American College of Rheumatology (ACR) annual meeting, from a study further investigating the efficacy, pharmacokinetics and safety, including immunogenicity, of CT-P13 SC over a one-year treatment period and after switching from CT-P13 IV to CT-P13 SC in people with rheumatoid arthritis (RA).

  5. Teva And Celltrion Announce The Availability Of TRUXIMA (Rituximab-abbs) Injection, The First Biosimilar To Rituxan (Rituximab) In The United States

    Teva Pharmaceuticals USA, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd., Celltrion, Inc., and Celltrion Healthcare, Co., Ltd., today announced that TRUXIMA (rituximab-abbs) injection is the first biosimilar to the reference product Rituxan (rituximab) now available in the United States with a full oncology label.

  6. China NMPA Approves Bio-Thera Solutions’ QLETLI, A Biosimilar To Humira (Adalimumab)

    Bio-Thera Solutions, Ltd., a clinical-stage pharmaceutical company, recently announced that the China National Medical Products Administration (NMPA) has approved QLETLI for all eligible indications of the reference product, Humira (adalimumab), in China.

  7. Alvotech And STADA Agree On Strategic Biosimilar Partnership

    Biopharmaceutical company Alvotech and global pharmaceutical company STADA Arzneimittel AG (“STADA”) recently announced that they have entered into an exclusive strategic partnership for the commercialization of seven biosimilars in all key European markets and selected markets outside Europe.

  8. Samsung Bioepis Enters Into Commercialization Agreement For Next-Generation Biosimilar Candidates

    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.

  9. Biogen To Expand Biosimilars Portfolio And Gain Access To Additional Markets Through New Transaction With Samsung Bioepis

    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.

  10. New White Paper To Detail European Biosimilar Evolution And Policy Principles

    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.