Biosimilar Development News

  1. 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.

  2. 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.

  3. 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.

  4. 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].

  5. 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.

  6. 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.

  7. Bio-Thera And Dr. Reddy's Execute Exclusive Commercialization Agreement For BAT2206, A Proposed Stelara® Biosimilar, And BAT2506, A Proposed Simponi® Biosimilar, For Southeast Asia 3/27/2025

    Bio-Thera Solutions (688177:SH; "Bio-Thera"), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, and Dr. Reddy's Laboratories SA, wholly-owned subsidiary of Dr. Reddy's Laboratories Ltd. (BSE: 500124 | NSE: DRREDDY| NYSE: RDY | NSEIFSC: DRREDDY, along with its subsidiaries hereafter referred to as "Dr. Reddy's"), announce today they have reached commercialization and license agreements for BAT2206, a proposed Stelara® biosimilar, and BAT2506, a proposed Simponi® biosimilar.

  8. Biosimilars Forum Executive Director Juliana Reed To Speak At Evolution Of Biosimilars Development Workshop 3/26/2025

    Juliana Reed, executive director of the Biosimilars Forum, will speak at the DIA Evolution of Biosimilar Development Workshop on May 21, 2025. Reed will discuss the current state of the biosimilars industry, highlighting the need for Americans to have increased access to lower-cost biosimilars.

  9. African Development Bank Approves EUR 15 Million Loan To Boost Biosimilars' Development And Production In Egypt 3/26/2025

    The Board of Directors of the African Development Bank (the “AfDB”) has approved a EUR 15 million senior corporate loan to Minapharm Pharmaceuticals S.A.E. (Minapharm), a leading biopharmaceutical company in Egypt.

  10. Biosimilars Forum Chair Of Scientific Affairs Committee To Speak At The Festival Of Biologics USA 3/24/2025

    Hillel P. Cohen, Chair of the Scientific Affairs Committee for the Biosimilars Forum, will speak at the Festival of Biologics USA 2025 on April 24, 2025, to discuss importance of streamlining biosimilar development.