Biosimilar Development News

  1. Polpharma Biologics Confirms U.S. Launch Of Tyruko (natalizumab), The First And Only Biosimilar For Multiple Sclerosis 11/17/2025

    Polpharma Biologics, a biopharmaceutical company group focused on biosimilars development and manufacturing, today confirmed that Sandoz Tyruko (natalizumab-sztn) is now available to patients in the United States.

  2. Milestone Achieved With FYB208: Biosimilar Candidate For Dupixent (Dupilumab) As Another Growth Driver In Formycon's Portfolio 11/17/2025

    Formycon AG (Prime Standard, “Formycon”) today announced details of one of its previously undisclosed development projects: FYB208 is a biosimilar candidate for the immunological blockbuster drug Dupixent1 (INN: dupilumab).

  3. AEON Biopharma Announces Fundraise Totaling Up to ~$22M Through Private Placement And Proposed Exchange Of Daewoong Convertible Notes 11/13/2025

     AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE American: AEON), a biopharmaceutical company seeking accelerated and full-label U.S. market entry by developing ABP-450 (prabotulinumtoxinA) as a BOTOX® (onabotulinumtoxinA) biosimilar, today announced two complementary transactions totaling up to ~$22 million in potential proceeds that will collectively transform the Company’s balance sheet, eliminate nearly all outstanding debt, and provide capital to accelerate program execution ahead of AEON’s upcoming FDA Type 2a meeting.

  4. EirGenix Signed The Commercial Licensing Agreement For Its Second HER2 Biosimilar Asset EG1206A 11/12/2025

    EirGenix Inc.(TWSE: 6589) today announced that it has entered into a second global exclusive licensing agreement with international biosimilar leader Sandoz AG (SIX:SDZ/OTCQX:SDZNY) for the commercialization of its independently developed breast cancer biosimilar, EG1206A (Pertuzumab Biosimilar to Roche Perjeta®), covering all territories except Taiwan, Mainland China, Macau, South Korea, Mongolia, Brunei, Cambodia, Indonesia, Laos, Myanmar, the Philippines, and Japan. The agreement further strengthens the two companies' collaborative development of the HER2 biosimilar product.

  5. Sandoz Signs Global License Agreement To Commercialize Breast Cancer Biosimilar pertuzumab 11/12/2025

    Sandoz, the global leader in affordable medicines, today announced the signing of a global license agreement to commercialize a proposed biosimilar of oncology medicine pertuzumab.

  6. UK High Court Rules In Favor Of Alvotech Paving Way For Manufacture And Market Entry Of AVT06, Biosimilar To Eylea® (aflibercept) 11/10/2025

    Alvotech, a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today the outcome of expedited infringement proceedings before the UK High Court by Regeneron Pharmaceuticals Inc. (“Regeneron”) and Bayer AG (“Bayer”) against Alvotech and its contract manufacturing organization (CMO) in the United Kingdom.

  7. Bio-Thera Solutions Expands Partnership With Dr. Reddy's Through An Exclusive Commercialization And License Agreement For BAT2306, A Proposed Biosimilar Candidate To Cosentyx (Secukinumab), In Southeast Asia 11/10/2025

    Bio-Thera Solutions, a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, today announced that it has entered into an exclusive commercialization and license agreement with Dr. Reddy’s Laboratories Ltd., for BAT2306, a proposed biosimilar candidate to Cosentyx (secukinumab).

  8. Samsung Bioepis Reaches Settlement Agreement For PYZCHIVA (ustekinumab) In Europe 11/6/2025

    Samsung Bioepis Co., Ltd. has signed a settlement and license agreement with Johnson & Johnson concerning the commercialization of PYZCHIVA, a biosimilar to Stelara (ustekinumab)1, in Europe. The terms of the agreement remain confidential.

  9. Mark Cuban Cost Plus Drug Company Expands Access With Addition Of Starjemza® (ustekinumab-hmny) To Give Patients More Power Over Prescription Costs 11/6/2025

    Mark Cuban Cost Plus Drug Company (Cost Plus Drugs) today announced the addition of Starjemza®, a new biosimilar medication, to its growing portfolio of affordable prescription drugs.

  10. Alvotech And Advanz Pharma Receive Marketing Authorisations For Gobivaz®, A Biosimilar To Simponi® (golimumab), From The MHRA 11/6/2025

    Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Advanz Pharma Holdco Limited (“Advanz Pharma”), a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe, today announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisations for all four presentations of Gobivaz®, Alvotech’s biosimilar to Simponi® (golimumab).