Biosimilar Development News

  1. 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).

  2. 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.

  3. 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").

  4. 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).

  5. 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.

  6. 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.

  7. 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).

  8. CMS Grants Fresenius Kabi COVID-19 Indication-Specific HCPCS Codes For Tyenne (tocilizumab-aazg) 4/9/2026

    Fresenius Kabi, a part of Fresenius, and a leading provider of essential medicines and medical technologies, announced today that the Centers for Medicare & Medicaid Services has issued indication-specific Healthcare Common Procedure Coding System (HCPCS) codes for Tyenne (tocilizumab-aazg) for the treatment of COVID-19.

  9. Aurobindo arm CuraTeQ Reports Positive Phase 3 Results For Allergy Drug BP11 4/7/2026

    Aurobindo Pharma’s wholly owned subsidiary, CuraTeQ Biologics, has reported positive top-line results from the Phase 3 trial of its omalizumab biosimilar, BP11, indicating comparable efficacy and safety to the reference drug, Xolair.

  10. Apotex Strengthens Osteoporosis Care In Canada With Health Canada's Approval Of DENOZA™, A Denosumab Biosimilar 4/7/2026

    Apotex Inc. ("Apotex" or the "Company"), the largest Canadian‑based global pharmaceutical company, today announced that Health Canada has approved DENOZA™ (denosumab injection), a biosimilar to Prolia®, for its authorized indications.