Biosimilar Development News

  1. Biocon Receives Health Canada Approval Of Bosaya (Denosumab) And Vevzuo (Denosumab), Biosimilars To Prolia And Xgeva 4/21/2026

    Biocon Limited, an innovation‑led global biopharmaceutical company, is pleased to announce that Health Canada has granted a Notice of Compliance (NOC) for Bosaya (denosumab), a biosimilar to Prolia, and Vezuo (denosumab), a biosimilar to Xgeva, on April 3, 2026.

  2. JAMP Pharma Group Strengthens Its Immunology Biosimilars Portfolio With PrUpgolyv™, A Golimumab Biosimilar That Has Receive Its Notice Of Compliance By Health Canada 4/20/2026

    With the authorization of PrUpgolyv™ (golimumab injection) by Health Canada, JAMP Pharma Group continues to build momentum in its immunology-focused biosimilars pipeline, delivering innovative, cost-effective treatment options for patients with inflammatory autoimmune diseases.

  3. Accord BioPharma's IMULDOSA® (ustekinumab-srlf) Now Preferred Under Cigna Healthcare Commercial Plans 4/20/2026

    Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals, Ltd., focused on the development of oncology and immunology therapies, announced IMULDOSA® (ustekinumab-srlf) is now covered by Cigna Healthcare, effective April 15, 2026.

  4. Mabwell Passes On-Site GMP Inspection By Regulatory Authority Of PIC/S Member Country (Jordan) For The First Time 4/20/2026

    Mabwell (688062.SH), an innovation-driven biopharmaceutical company with a fully integrated industry chain, announced that its wholly-owned subsidiary, T-mab, has successfully passed the on-site GMP inspection conducted by the Jordan Food and Drug Administration (JFDA).

  5. Samsung Bioepis Highlights Consistent Efficacy Of SB16 (OBODENCE; Denosumab) Across Osteoporosis Patient Subgroups At WCO-IOF-ESCEO 2026 4/17/2026

    Samsung Bioepis Co., Ltd. announced today new data supporting consistent efficacy of SB16 (OBODENCE1), a biosimilar to Prolia2  (denosumab) across patient subgroups compared to the reference denosumab.

  6. Mabwell Establishes A Licensing And Commercialization Agreement For Denosumab Biosimilars In Malaysian Market 4/16/2026

    Mabwell (688062.SH), an innovation-driven biopharmaceutical company with a fully integrated industry chain, announced that it has established a licensing and commercialization agreement with a strategic business partner ("the partner") in Malaysia for its Denosumab biosimilar products MAILISHU (a biosimilar of Prolia®) and MAIWEIJIAN (a biosimilar of Xgeva®) ("the products").

  7. NMPA Grants IND Approval For Henlius' Cetuximab Biosimilar HLX05-N 4/14/2026

    Henlius announced that the Investigational New Drug (IND) application for its self-developed cetuximab biosimilar HLX05-N (recombinant anti-EGFR human-mouse chimeric monoclonal antibody injection) has been approved by the National Medical Products Administration (NMPA) for the treatment of metastatic colorectal cancer (mCRC).

  8. Twenty Years Of Biosimilar Medicines: A Milestone That Continues To Transform Patient Access Worldwide 4/13/2026

    Sandoz, the global leader in affordable medicines, today celebrates the 20th anniversary of European regulatory approval for Omnitrope (somatropin) as the world’s first-ever biosimilar medicine.

  9. Henlius Announces First Patient Dosed In Clinical Trial Of HLX319, China's First Subcutaneous Fixed-Dose Injection Of A Pertuzumab/Trastuzumab Biosimilar 4/10/2026

    Henlius today announced that the first patient has been dosed in China in HLX319-001, a phase 1 clinical trial of HLX319, the company's self-developed, fixed-dose subcutaneous injection of pertuzumab and trastuzumab. As a fixed-dose subcutaneous combination, HLX319 allows trastuzumab and pertuzumab administration in 5 minutes without weight-based dose adjustment, offering comparable efficacy and safety to intravenous regimens and greatly facilitating clinical use.

  10. The rituximab With The Most Approved Indications Domestically, Henlius' HANLIKANG Has Obtained Approvals For Two Additional Indications 4/9/2026

    On April 9, 2026, Henlius announced that the supplemental application for two new indications under non-Hodgkin's lymphoma of HANLIKANG (rituximab), independently developed and manufactured by the company, was approved by the National Medical Products Administration (NMPA).