Biosimilar Development News

  1. Biocon Biologics Secures U.S. Market Entry Date For Bosaya And Aukelso, Denosumab Biosimilars 10/1/2025

    Biocon Biologics Ltd. (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd., today announced a settlement and license agreement with Amgen Inc. that clears the path for the commercialization of Bosaya (denosumab-kyqq) and Aukelso (denosumab-kyqq) in the United States.

  2. U.S. FDA Clearance Of IND For Ipilimumab Biosimilar HLX13 9/30/2025

    Shanghai Henlius Biotech, Inc. announced the investigational new drug (IND) application for its HLX13, a proposed ipilimumab biosimilar independently developed by the company, was approved by the U.S. Food and Drug Administration (FDA) as a first-line treatment for patients with unresectable hepatocellular carcinoma.

  3. Hikma And Richter Receive FDA Approval For denosumab Biosimilars Enoby(denosumab- qbde) And Xtrenbo (denosumab- qbde) Referencing Prolia And Xgeva Respectively 9/29/2025

    Gedeon Richter Plc. (“Richter”) and Hikma Pharmaceuticals Plc. along with its wholly owned subsidiary Hikma Pharmaceuticals USA Inc. (“Hikma”) announce today that the U.S. Food and Drug Administration (FDA) has granted approval for the Biologics License Applications (BLA) of their biosimilar denosumab products, Enoby (denosumab-qbde) and Xtrenbo (denosumab-qbde), referencing Prolia and Xgeva respectively.

  4. Amneal Announces BLA Submission Of Biosimilar Candidate To XOLAIR® (omalizumab) 9/26/2025

    Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for a proposed biosimilar to XOLAIR® (omalizumab), developed by Kashiv BioSciences, LLC. XOLAIR® is a registered trademark of Novartis AG.

  5. Bora Biologics To Manufacture NYPOZI At San Diego Facility In Partnership With InvaGen Pharmaceuticals, A Cipla Group Company 9/25/2025

    Bora Biologics, a leading contract development and manufacturing organization (CDMO) specializing in biologics, proudly announces its partnership with InvaGen Pharmaceuticals Inc., a wholly owned subsidiary of Cipla Limited, for the manufacture of NYPOZI (biosimilar to Neupogen) at its FDA-registered facility in San Diego, California.

  6. JAMP Pharma Group Launches PrPexegra® (pegfilgrastim) And PrFilra® (filgrastim), Two New Biosimilar Therapeutic Options In Oncology 9/24/2025

    JAMP Pharma Group, a leading Canadian pharmaceutical organization, is proud to announce today the launch of two biosimilar products in oncology, PrPexegra® and PrFilra®.

  7. Kashiv BioSciences And JAMP Pharma Corporation Announce The Launch Of PEXEGRA And FILRA Biosimilars In Canada 9/24/2025

    Kashiv BioSciences, LLC today announced the commercial launch of PEXEGRA, a biosimilar referencing Neulasta, and FILRA, a biosimilar referencing Neupogen, in the Canadian market. Both biosimilars will be marketed in Canada through an exclusive agreement with JAMP Pharma Corporation.

  8. New Hope For Breast Cancer Patients – Hetero Healthcare Rolls Out Affordable Perzea In India 9/22/2025

    Hetero Healthcare Ltd., one of India’s leading pharmaceutical companies, has launched Perzea, the most affordable biosimilar of Pertuzumab, in collaboration with Enzene Biosciences Ltd.

  9. The Biosimilars Forum Applauds Representative Pfluger (R – TX) And Representative Landsman (D – OH) For Helping Make Lower-Cost Medicines Available To Americans 9/22/2025

    Representative August Pfluger (R – TX) and Representative Greg Landsman (D – OH) proposed important legislation to reduce regulatory red tape to help ensure lower-cost biosimilars are available to Americans who need them.

  10. European Medicines Agency Recommends Marketing Approval Of Gobivaz®, Alvotech's Proposed Biosimilar To Simponi® (golimumab) With Advanz Pharma As Commercialization Partner 9/22/2025

    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 European Medicines Agency’s (EMA) Committee for Medicinal Products for Human use (CHMP) has adopted a positive opinion recommending approval for Gobivaz®, Alvotech’s proposed biosimilar to Simponi® (golimumab), a biologic used to treat several chronic inflammatory diseases.