Biosimilar Development News

  1. Biosimilars Forum Urges Congressional Action On Biosimilars 4/8/2025

    Juliana M. Reed, executive director of the Biosimilars Forum, released the following statement after the House Ways and Means Health Subcommittee hearing on “Lowering Costs for Patients: The Health of the Biosimilar Market.”

  2. Teva And Samsung Bioepis Announce Biosimilar EPYSQLI® (eculizumab-aagh) Injection Now Available In The United States 4/8/2025

    Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Samsung Bioepis Co., Ltd. today announced the availability of EPYSQLI® (eculizumab-aagh) in the U.S. EPYSQLI is a biosimilar to Soliris® (eculizumab) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS) and generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) antibody positive.

  3. Biosimilars Forum Supports The FDA, Its Employees, And Its Mission 4/2/2025

    Juliana M. Reed, executive director of the Biosimilars Forum, released the following statement about the U.S. Food and Drug Administration (FDA) and its recent loss of institutional knowledge and expertise through reductions in force.

  4. Accord Healthcare Receives Positive CHMP Opinion For Denosumab, Osvyrti®, And Jubereq® 4/2/2025

    Accord Healthcare Limited (Accord) is pleased to announce that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Denosumab, including its branded formulations Osvyrti® and Jubereq®, across its autoimmune and oncology therapy areas.

  5. Organon Acquires TOFIDENCE (tocilizumab-bavi), A Commercialized Biosimilar To ACTEMRA (tocilizumab) Injection, For Intravenous Infusion In The U.S. 4/1/2025

    Organon, a global healthcare company with a deep expertise in biosimilars, today announced that it has acquired from Biogen Inc. regulatory and commercial rights in the U.S. for TOFIDENCE, a biosimilar to ACTEMRA, for intravenous infusion.

  6. Celltrion's Remdantry, Previously Known As Inflectra, Will Be Available In Canada As Of April 1, 2025 3/28/2025
  7. UK Medicines And Healthcare Products Regulatory Agency Confirms Acceptance Of Marketing Authorization Application For Proposed Biosimilar To Xolair® (omalizumab) 3/28/2025

    Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacturing of biosimilar medicines for patients worldwide, Kashiv Biosciences LLC (“Kashiv”), a fully integrated biopharmaceutical company headquartered in New Jersey, US, and Advanz Pharma, a UK-headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines, today announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has accepted a marketing application for AVT23, a proposed biosimilar to Xolair® (omalizumab), a biologic indicated for treatment of severe persistent allergic asthma and chronic rhinosinusitis with nasal polyps. Global sales of Xolair in 2024 were about USD $4.4 billion [1].

  8. European Medicines Agency (EMA) Validates Henlius And Organon Filing For Perjeta (pertuzumab) Biosimilar Candidate HLX11 3/28/2025

    Shanghai Henlius Biotech, Inc. (2696.HK) and Organon today announced that the European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for HLX11, an investigational biosimilar of Perjeta (pertuzumab).

  9. Alvotech Appoints Dr. Balaji V. Prasad As Chief Strategy Officer 3/27/2025

    Alvotech (NASDAQ: ALVO, or the “Company”), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced the appointment of Dr. Balaji V. Prasad as Chief Strategy Officer.

  10. Celltrion's STEQEYMA® (ustekinumab-stba), Now Added To The Costco Member Prescription Program 3/27/2025

    Celltrion, Inc., today announced that STEQEYMA® (ustekinumab-stba), a biosimilar to STELARA® (ustekinumab) has been added to the Costco Member Prescription Program.