Biosimilar Development News

  1. Xbrane Re-Submits BLA For Ranibizumab Biosimilar Candidate To FDA 12/3/2024

    Xbrane Biopharma AB (publ) ("Xbrane" or "the Company") has re-submitted the BLA (Biologics License Application) for its investigational biosimilar candidate to LUCENTIS (ranibizumab) to FDA (US Food and Drug Administration).

  2. Accord BioPharma Announces Agreement By Intas Pharmaceuticals, Ltd. To Acquire UDENYCA® (pegfilgrastim-cbqv) Business From Coherus BioSciences, Inc., Unlocking Potential For Continued U.S. Growth 12/3/2024

    Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd. ("Intas Pharmaceuticals"), focused on the development of oncology, immunology and critical care therapies, announced today that Intas Pharmaceuticals has signed an agreement to acquire the UDENYCA® (pegfilgrastim-cbqv) business from Coherus BioSciences, Inc. ("Coherus").

  3. U.S. FDA Approves Biocon Biologics' YESINTEK™, Bmab 1200 Biosimilar To J&J's Stelara® (Ustekinumab) 12/2/2024

    Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), announced today that the U.S. Food and Drug Administration (FDA) has approved YESINTEK™ (Ustekinumab-kfce), a biosimilar to the reference product, Stelara® (Ustekinumab).

  4. First Shipment Of Henlius Trastuzumab To U.S. 11/29/2024

    On November 29, 2024, Henlius' independently developed and produced trastuzumab biosimilar, HANQUYOU (trade name: HERCESSI in the U.S. and Zercepac in Europe), departed from Henlius’ Songjiang First Plant, heading to the U.S. This milestone marks the company’s first commercial supply to North America, representing a significant breakthrough in its global expansion.

  5. Boan Reached A Strategic Cooperation For Denosumab In Brazil 11/26/2024

    Boan Biotech announced that it has signed a licensing agreement for commercializing its self-developed Denosumab Injection (BA6101 and BA1102) in the Brazilian market with a strategic partner.

  6. Bio Usawa And Rwandan Government Sign A Memorandum Of Understanding To Manufacture Affordable Biologics In Africa 11/21/2024

    Bio Usawa and the Rwanda Development Board have partnered to establish Rwanda’s first manufacturing plant for affordable treatments for serious eye diseases like diabetic macular edema.

  7. Xbrane And Intas Enter Into A Global Licensing Agreement To Jointly Develop Nivolumab Biosimilar Referencing Opdivo 11/19/2024

    Intas secures exclusive global commercialization rights for Xbrane´s Nivolumab biosimilar candidate, (referencing Opdivo). Opdivo achieved global sales of USD 9 billion in 2023.

  8. Celltrion Presents Additional Data From Phase III Randomized Controlled Trials To Further Support Biosimilarity For CT-41 (Biosimilar Candidate Of denosumab) And CT-P47 (tocilizumab) At American College Of Rheumatology (ACR) Convergence 2024 11/18/2024

    Celltrion today presented additional data from a Phase III randomized controlled trial (RCT) for CT-P41, a biosimilar candidate referencing PROLIA®/XGEVA® (denosumab) in postmenopausal women with osteoporosis (PMO) and a Phase III RCT for CT-P47, a biosimilar candidate referencing ACTEMRA® (tocilizumab) in patients with moderate-to-severe active rheumatoid arthritis (RA) at the American College of Rheumatology (ACR) Convergence 2024 in Washington, D.C.

  9. Samsung Bioepis And Biogen Receive European Commission (EC) Approval For Aflibercept Biosimilar, OPUVIZ™ 11/18/2024

    Samsung Bioepis Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) today announced that the European Commission (EC) has approved OPUVIZ™ 40 mg/mL solution for injection in a vial, a biosimilar referencing Eylea1,2 (aflibercept), developed and registered by Samsung Bioepis.

  10. Sandoz Receives European Commission Approval For Afqlir® (aflibercept), Further Strengthening Leading Biosimilar Portfolio 11/15/2024

    ndoz (SIX:SDZ/OTCQX:SDZNY), the global leader in generic and biosimilar medicines, today announced that the European Commission (EC) has granted marketing authorization for Afqlir® (aflibercept) 2 mg vial kit and pre-filled syringe for intravitreal injection, a biosimilar to reference medicine Eylea®*[1,2].