Biosimilar Development News

  1. Biologics & Biosimilars Collective Intelligence Consortium Awarded $1.4M Grant From The FDA 10/10/2023

    The Biologics & Biosimilars Collective Intelligence Consortium (BBCIC) today announced that it has been awarded a $1.4M grant from the Food & Drug Administration (FDA) to enable biosimilar research.

  2. FDA Approves TOFIDENCE™ (tocilizumab-bavi) A Biosimilar Of ACTEMRA® Developed By Bio-Thera Solutions 10/8/2023

    Bio-Thera Solutions, Ltd (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of biosimilars and innovative assets, announced that its partner Biogen recently received notification from the United States Food and Drug Administration (FDA) on the approval of TOFIDENCE (tocilizumab-bavi) intravenous formulation, a biosimilar monoclonal antibody referencing ACTEMRA.

  3. Samsung Bioepis Presents Post-Hoc Analysis Of Phase 3 Clinical Trial For SB15, A Proposed Biosimilar To Eyleaⁱ (Aflibercept), At EURETINA 2023 10/7/2023

    Samsung Bioepis Co., Ltd. today announced that it presented a post-hoc analysis of the Phase 3 clinical study results for SB15, a proposed biosimilar to Eylea (aflibercept), at EURETINA 2023 being held from October 5 to 8 in Amsterdam, the Netherlands.

  4. FDA Grants Interchangeable Designation To Pfizer’s Biosimilar ABRILADA 10/5/2023

    Pfizer Inc. today announced that the U.S. Food and Drug Administration (FDA) has designated ABRILADA (adalimumab-afzb) as an interchangeable biosimilar to Humira (adalimumab).

  5. Sandoz Enters New Era As Standalone Global Leader And European Champion In Generic And Biosimilar Medicines 10/4/2023

    Sandoz, the global leader in generic and biosimilar medicines, today celebrates the start of share trading on the SIX Swiss Exchange as an independent company.

  6. CIMERLI® (ranibizumab-eqrn) Sales Exceed 100,000 Doses In First Year Of Launch 10/4/2023

    Coherus BioSciences, Inc. (Coherus, Nasdaq: CHRS), today announced that sales of CIMERLI® (ranibizumab-eqrn) to retinal specialists have exceeded 100,000 doses since commercial launch on October 3, 2022.

  7. Alvotech Enters Into Exclusive Licensing Agreement With Kashiv Biosciences For Development And Commercialization Of A Proposed Biosimilar To Xolair® (Omalizumab) 10/3/2023

    Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Kashiv Biosciences LLC (“Kashiv”), a fully integrated biopharmaceutical company, today announced that they have entered into an exclusive licensing agreement for AVT23 (also called ADL018), a proposed biosimilar to Xolair® (omalizumab), which is currently in clinical development.

  8. ProciseDx Announces The First FDA-Cleared Therapeutic Drug Monitoring Tests For Biologic Drugs, Humira®, Remicade®, And Their Biosimilars 10/3/2023

    ProciseDx Inc. announces that it has been granted de novo FDA clearance for the therapeutic drug monitoring (TDM) tests for adalimumab (Humira® and biosimilar Amgevita®) and infliximab (Remicade® and biosimilars Inflectra® and Renflexis®).

  9. Kashiv BioSciences Enrolls First Patient In Phase III Clinical Study For ADL018, A Biosimilar Candidate To XOLAIR (omalizumab) 10/2/2023

    Kashiv BioSciences, LLC (“Kashiv” or the “Company”) today announced that it has enrolled the first patient in its Phase III clinical study involving ADL018, the Company’s biosimilar candidate to XOLAIR. 

  10. Adalimumab-adbm, Boehringer Ingelheim's Interchangeable Biosimilar To Humira®, Now Available At Low Wholesale Acquisition Cost 10/2/2023

    Boehringer Ingelheim announced today that Adalimumab-adbm injection, the company's interchangeable* biosimilar to Humira® (adalimumab), is now available at a low wholesale acquisition cost (WAC).