Biosimilar Development News

  1. Samsung Bioepis Announces US Launch Of PYZCHIVA (ustekinumab-ttwe), Biosimilar To Stelara 2/24/2025

    Samsung Bioepis Co., Ltd. today announced that PYZCHIVA (ustekinumab-ttwe), a biosimilar to Stelara (ustekinumab), is now available in the United States.

  2. 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.

  3. 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.

  4. Celltrion Receives EC Approval For Avtozma (CT-P47), A Biosimilar To RoActemra (tocilizumab) 2/23/2025

    Celltrion today announced that the European Commission (EC) has granted marketing authorization for Avtozma (CT-P47), a biosimilar referencing RoActemra® (tocilizumab).

  5. 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.

  6. 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).

  7. Alvotech And Teva Announce Filing Acceptance Of U.S. Biologics License Application For AVT06, A Proposed Biosimilar To Eylea® (aflibercept) 2/18/2025

    Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT06, Alvotech’s proposed biosimilar to Eylea® (aflibercept), a biologic used to treat eye disorders, including diseases which can lead to vision loss or blindness.

  8. Celltrion Expands Biosimilar Portfolio In The European Union Following European Commission Approval Of Two Biosimilars 2/18/2025

    Celltrion today announced that the European Commission (EC) has granted marketing authorization for three products across two biosimilars: Eydenzelt (CT-P42, aflibercept), a biosimilar to Eylea to treat multiple retinal disorders, including neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO, branch RVO or central RVO), diabetic macular edema (DME) and myopic choroidal neovascularisation (myopic CNV); and Stoboclo and Osenvelt (CT-P41, denosumab), biosimilars referencing Prolia and Xgeva used for all indications of the reference products.

  9. Phase 3 Trial Results Of Boan Biotech's BA1102 (Denosumab Injection) Published In Journal Of Bone Oncology 2/17/2025

    The Phase 3 trial results of Boan Biotech’s anti-tumor denosumab injection (Chinese trade name: Boluojia, code-named BA1102, and formerly code-named LY01011) were recently published in Journal of Bone Oncology.

  10. FDA Approves Samsung Bioepis' OSPOMYV, XBRYK (denosumab-dssb), A Biosimilar To Prolia And Xgeva 2/15/2025

    Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for OSPOMYV (denosumab-dssb; SB16; 60 mg pre-filled syringe) and XBRYK (denosumab-dssb; SB16; 120 mg vial), biosimilars referencing Prolia and Xgeva respectively.