Tagged as: biosimilar

OcyonBio Announces Biosimilar Solutions to Begin GMP Manufacturing in Puerto Rico

Last week, OcyonBio announced a manufacturing and operations agreement to develop biosimilar drug product facilities for Biosimilar Solutions, Inc. in Puerto Rico. According to the press release “OcyonBio is creating an advanced therapy contract development, manufacturing organization (CDMO) that provides pre-clinical through commercial manufacturing, including process development, plasmid DNA, viral…

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JAMA Oncology Publishes Results of Phase III Study for Prestige BioPharma’s HERCEPTIN Biosimilar, HD201

On March 14, 2022, Prestige BioPharma Ltd., a Singapore-based biopharmaceutical company, announced positive safety and efficacy results in a Phase III study (“TROIKA”) for HD201, a biosimilar to HERCEPTIN (trastuzumab). The results of the TROIKA study were published in JAMA Oncology on March 3, 2022. In the double-blind trial, researchers…

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Adalimumab Biosimilar Wins NMPA Approval

Shanghai Junshi Biosciences Co. Ltd. and Mabwell Bioscience Co. Ltd. announced that the jointly developed adalimumab biosimilar injection (Junmaikang ®) was officially approved by the Chinese National Medical Products Administration (NMPA) for marketing authorization (drug approval number: Sinopharm S20220008). Junmaikang® is used for the treatment of rheumatoid arthritis, ankylosing spondylitis,…

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Samsung Bioepis Clinical Trial Updates

On December 8, Samsung Bioepis announced that it had presented the longest follow-up study results for a trastuzumab biosimilar in patients with HER2-positive early or locally advanced breast cancer.  The five-year study compared long-term survival rates of patients on SB3 (ONTRUZANT®, Samsung Bioepis’ biosimilar of Herceptin®) and Herceptin® (trastuzumab) from…

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Biosimilar Partnership News

Eris Lifesciences (“Eris”) announced its joint venture with Mumbai-based MJ Biopharm Pvt Ltd. (“MJ”),  Eris MJ Biopharm Ltd.,  focused on the marketing and distribution of insulins (including aspart, glargine and lispro), GLP1 agonists, and potentially other biopharma products in India.  Under the agreement, MJ will be responsible for the development,…

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Final Judgment and Order of Permanent Injunction Entered in Immunex v. Samsung Bioepis Etanercept Biosimilar Litigation

The New Jersey district court in the Immunex v. Samsung Bioepis BPCIA litigation entered a Final Judgment and Order of Permanent Injunction on November 3, 2021.  As we previously reported, the litigation pertains to ETICOVO (etanercept-ykro), Samsung Bioepis’s biosimilar of ENBREL.  The case had been administratively stayed since January 2020. Judgment…

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FDA Approves First Interchangeable Biosimilar Insulin Product (UPDATE - 11/23/2021)

July 28, 2021 – the U.S. Food and Drug Administration (FDA) approved Viatris Inc.’s (formerly Mylan Pharmaceuticals Inc.) SEMGLEE (insulin glargine-yfgn), a biosimilar to LANTUS (insulin glargine). According to the press release, SEMGLEE is indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and…

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