Biosimilar Development News

  1. Samsung Bioepis Initiates Phase 1 Clinical Trial For SB27, Proposed Biosimilar To Keytruda (Pembrolizumab) 2/21/2024

    Samsung Bioepis Co., Ltd. today announced the initiation of Phase 1 clinical trial for SB27, the company's proposed biosimilar referencing Keytruda (pembrolizumab).

  2. Coherus Announces U.S. Launch Of UDENYCA ONBODY™ A Novel And Proprietary State-Of-The-Art Delivery System For pegfilgrastim-cbqv 2/21/2024

    Coherus BioSciences, Inc. (Coherus, NASDAQ: CHRS) today announced the launch of UDENYCA ONBODY™, the company's on-body injector (OBI) presentation of UDENYCA® (pegfilgrastim-cbqv), is successfully underway, with a broad distribution of accounts nationwide ordering this innovative device, and patients now accessing its benefits.

  3. Organon Announces HADLIMA (adalimumab-bwwd) Has Been Exclusively Selected By The US Department Of Veterans Affairs (VA), Replacing HUMIRA On Its National Formulary 2/20/2024

    Organon, a global healthcare company with a dedicated commitment to biosimilars, announced that the US Department of Veterans Affairs (VA) has exclusively selected HADLIMA in replacement of HUMIRA (adalimumab) for the VA National Formulary.

  4. Sandoz Receives Health Canada Approval For Jubbonti®, First And Only denosumab Biosimilar For Treatment Of Osteoporosis 2/20/2024

    Sandoz Canada is pleased to announce that Health Canada has provided authorization to market Jubbonti® (denosumab subcutaneous injection, reference medicine: Prolia*).

  5. Alvotech Announces Expected Global Market Entry Dates For AVT04 Biosimilar To Stelara® (ustekinumab) 2/15/2024

    Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that it has reached settlement agreements with Johnson & Johnson in Japan, Canada and in the European Economic Area (EEA) for AVT04, a biosimilar to Stelara® (ustekinumab).

  6. Biocon Biologics Partners With Sandoz Australia For Biosimilars Trastuzumab And Bevacizumab 2/8/2024

    Biocon Biologics Ltd (BBL), a fully integrated biosimilars company and subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), today announced a five-year partnership with Sandoz AG ('Sandoz') which provides Sandoz the exclusive rights to promote, sell and distribute biosimilar Trastuzumab (market value of AUD$35 million1) and biosimilar Bevacizumab (market value of AUD$45 million2) in Australia.

  7. Novo Holdings To Acquire CDMO Catalent Pharma Solutions For $16.5 Billion 2/5/2024

    Catalent, Inc. (NYSE: CTLT), a leader in enabling the development and supply of better treatments for patients worldwide, and Novo Holdings, a holding and investment company that is responsible for managing the assets and wealth of the Novo Nordisk Foundation, today announced that they have entered into a merger agreement under which Novo Holdings will acquire Catalent in an all-cash transaction that values Catalent at $16.5 billion on an enterprise value basis.

  8. Rani Therapeutics Announces Positive Topline Results From Phase 1 Study Of An Oral Anti-Interleukin 12/23 Antibody (RT-111) 2/5/2024

    Rani Therapeutics Holdings, Inc. (“Rani Therapeutics” or “Rani”) (Nasdaq: RANI), a clinical-stage biotherapeutics company focused on the oral delivery of biologics and drugs, today announced positive topline results from its Phase 1 clinical study of RT-111, a RaniPill® capsule containing an ustekinumab biosimilar, CT-P43.

  9. Henlius Announces Successful Completion Of Phase 1 PK Similarity Clinical Study Of Denosumab HLX14 2/1/2024

    Shanghai Henlius Biotech, Inc. (2696.HK) announced that a phase 1 clinical trial of the company’s denosumab biosimilar HLX14, a recombinant anti-RANKL human monoclonal antibody injection, met its primary endpoint.

  10. rBIO Completes Analytical Characterizations Of R-biolin, Readies Biosimilar Insulin Drug For Clinical Trial 2/1/2024

    rBIO Co., an emerging biotechnology company dedicated to reducing the cost of life-saving medicines, has successfully completed all required analytical characterizations of its insulin biosimilar, R-biolin.