Biosimilar Development News

  1. Professor Sarfaraz Niazi Of Washington State University Files FDA Citizen Petition Seeking New Pathway To Make High-Cost Medicines More Accessible Worldwide 8/25/2026

    Professor Sarfaraz K. Niazi of the College of Pharmacy and Pharmaceutical Sciences at Washington State University has submitted a Citizen Petition to the U.S. Food and Drug Administration, requesting the establishment of a new and unified scientific framework that could potentially revolutionize the development process for follow-on versions of FDA-approved medications.

  2. AEON Biopharma Designates Former FDA Neuroscience Leader Paul Lee, M.D., Ph.D. As Acting Chief Regulatory Officer 8/24/2026

    AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE American: AEON), a biopharmaceutical company advancing ABP-450 as a biosimilar to BOTOX® (onabotulinumtoxinA) for therapeutic use to achieve full-label U.S. market entry, today announced the designation of Paul Lee, M.D., Ph.D. as the Company’s acting Chief Regulatory Officer, through Clintrex, strengthening the Company's regulatory leadership.

  3. Celltrion Expands Omlyclo Portfolio In Europe With Launch Of 300 Mg Strength 8/24/2026

    Celltrion today announced the launch of the 300 mg strength of Omlyclo (omalizumab), a treatment for chronic spontaneous urticaria and allergic asthma, in Europe.1

  4. Amneal Announces U.S. Expansion Of End-To-End Biosimilars Development With Acquisition Of Kashiv BioSciences 8/21/2026

    The Association for Accessible Medicines today commented on the announcement by Amneal Pharmaceuticals, Inc. of the completion of their acquisition of U.S. based Kashiv BioSciences, which creates a fully end-to-end biosimilars capacity, from research, development, manufacturing, and commercialization.

  5. Alvotech Announces Licensing And Commercialization Agreement With Lotus Pharmaceutical For Proposed Biosimilars To Durvalumab And Emicizumab In The U.S. And Selected Asian Markets 8/21/2026

    Alvotech (NASDAQ: ALVO; ALVO-SDB), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced a strategic licensing and commercialization agreement with Lotus Pharmaceutical (TWSE Stock Code: 1795) covering two of Alvotech’s candidates in the United States and selected Asian markets: AVT34, a proposed biosimilar to Imfinzi® (durvalumab), and AVT87, a proposed biosimilar to Hemlibra® (emicizumab).

  6. AEON Reports Expanded Structural Data Supporting Molecular Similarity Of ABP-450 To BOTOX® 8/19/2026

    AEON Biopharma, Inc. ("AEON" or the "Company") (NYSE American: AEON), a biopharmaceutical company advancing ABP-450 as a biosimilar to BOTOX® (onabotulinumtoxinA) for therapeutic use to achieve full-label U.S. market entry, today announced final, expanded primary structure results and preliminary disulfide bond characterization data that provide complementary evidence supporting the molecular similarity of ABP-450 to BOTOX®.

  7. Avalon Pharma And Bio-Thera Execute Exclusive Commercialization Agreement For BAT2406, A Proposed Dupixent Biosimilar, For MENA 8/18/2026

    Avalon Pharma (Middle East Pharmaceutical Industries Company), a leading Saudi-based pharmaceutical manufacturer and Bio-Thera Solutions, Ltd., a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, announce today they have executed commercialization and license agreements for BAT2406, a proposed Dupixent biosimilar, for Saudi Arabia and the rest of the MENA region.

  8. Henlius And Sandoz Enter Strategic Collaboration To Unlock Global Value Of Biosimilars Platform 8/17/2026

    On August 17, 2026, Shanghai Henlius Biotech, Inc. (2696.HK) announced that it has entered into a strategic collaboration with Sandoz (SIX: SDZ; OTCQX: SDZNY), a global leader in generics and biosimilars, covering up to 10 proposed monoclonal antibody (mAb) and/or antibody-drug conjugate (ADC) biosimilar products or components developed by Henlius.

  9. New Study From CVS Caremark And Employee Benefit News Shows How Employers Rely On Their Pharmacy Benefit Manager To Create Sustainable Pharmacy Solutions 8/12/2026

    CVS Caremark, part of CVS Health® (NYSE: CVS), today announced the findings of a survey conducted in partnership with Employee Benefit News that reveals why employers are increasingly relying on their pharmacy benefit manager (PBM) partners to use their expertise, scale and purchasing power to help them manage their top concern: battling rising drug prices and maintaining access to quality care.

  10. Mabwell Announces Strategic Partnerships For Aflibercept Biosimilar In Multiple ASEAN Countries 8/11/2026

    Mabwell, an innovation-driven biopharmaceutical company with a fully integrated industry chain, announced that it has recently entered into licensing and commercialization agreements with local partners in the Philippines, Vietnam, and Malaysia respectively for its aflibercept biosimilar product.