Biosimilar Development News

  1. STEQEYMA® (ustekinumab-stba), A Biosimilar To STELARA® (ustekinumab), Now Available In The United States 3/12/2025

    Celltrion today announced the U.S. launch of STEQEYMA® (ustekinumab-stba), a biosimilar to STELARA® (ustekinumab), following approval by the U.S. Food and Drug Administration (FDA) in December 2024.

  2. U.S. FDA Approves Celltrion's OMLYCLO® (omalizumab-igec) As The First And Only Biosimilar With Interchangeability Designation Referencing XOLAIR® 3/9/2025

    Celltrion today announced the U.S. Food and Drug Administration (FDA) approved OMLYCLO® (omalizumab-igec) as the first and only biosimilar designated as interchangeable with XOLAIR® (omalizumab) for the treatment of moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), Immunoglobulin E (IgE)-mediated food allergy, and chronic spontaneous urticaria (CSU).

  3. Biocon Biologics Announces Positive Results From Phase 3 Study Of Yesintek™ Biosimilar To Ustekinumab For Chronic Plaque Psoriasis 3/7/2025

    Biocon Biologics Ltd. (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd. (BSE code: 532523, NSE: BIOCON), today announced the successful results of a pivotal Phase 3, randomized, double-blind, parallel group, multicenter study comparing Yesintek™ (Biocon Biologics' biosimilar to Ustekinumab, called YESINTEK) with reference product Stelara (Ustekinumab) in adult patients with moderate to severe chronic plaque psoriasis (PsO).

  4. Biosimilars Canada Announces Board Chair And Vice-Chair For 2025 3/3/2025

    Biosimilars Canada is pleased to announce the unanimous election of Mike Casia, President and Managing Director of Organon Canada, as Chair of Biosimilars Canada for 2025.

  5. Celltrion Receives U.S. FDA Approval For STOBOCLO® (denosumab-bmwo) And OSENVELT® (denosumab-bmwo) Biosimilars Referencing PROLIA® And XGEVA® 3/3/2025

    Celltrion today announced that the U.S. Food and Drug Administration (FDA) has approved STOBOCLO® (CT-P41, denosumab-bmwo) and OSENVELT® (CT-P41, denosumab-bmwo), biosimilars referencing PROLIA® (denosumab) and XGEVA® (denosumab) respectively for all indications of reference products.

  6. Sandoz Launches Biosimilar Pyzchiva® (ustekinumab-ttwe) In The US, Offering New Treatment For Around 12 Million Patients[1-4] 2/24/2025

    Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in generic and biosimilar medicines, announces the launch of Pyzchiva®* (ustekinumab-ttwe) in the US. From today, the medicine is commercially available to patients across the US.

  7. Biocon Biologics Launches Yesintek™ (ustekinumab-kfce) Biosimilar To Stelara® In The United States 2/24/2025

    Biocon Biologics Ltd. (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd. (BSE code: 532523, NSE: BIOCON), today announced that YESINTEK™ (ustekinumab-kfce) is now available to patients in the United States, and is one of the first Stelara® (ustekinumab) biosimilar market entrants in the country.

  8. Apotex Licenses Exclusive Canadian Rights To Qutenza® From Grünenthal 2/24/2025

    Apotex Inc. ("Apotex"), the largest Canadian-based pharmaceutical company, and Grünenthal, a global leader in pain management and related diseases, announced today that they have entered into a strategic licensing agreement whereby Apotex will have the exclusive Canadian rights to Qutenza®, a topical, non-systemic, non-opioid pain patch indicated for the management of neuropathic pain.

  9. Teva And Alvotech Announce SELARSDI (ustekinumab-aekn) Injection Now Available In The U.S. 2/21/2025

    Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Alvotech (NASDAQ: ALVO) today announced the availability of SELARSDI™ (ustekinumab-aekn) injection in the U.S., a biosimilar to Stelara® (ustekinumab), for the treatment of psoriatic arthritis, plaque psoriasis, Crohn’s disease, ulcerative colitis, pediatric plaque psoriasis and pediatric psoriatic arthritis.

  10. Clinical And Translational Science Publishes Phase 1 Clinical Results Of Henlius' HLX14 2/18/2025

    Recently, results from the phase 1 clinical study (NCT04534582) of Henlius’ denosumab biosimilar candidate HLX14 (a recombinant anti-RANKL human monoclonal antibody injection) was published in Clinical and Translational Science (IF 3.1).