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Samsung Biologics Completes Full Acquisition of Samsung Bioepis

In January 2022, Biogen Inc. announced it had reached an agreement to sell its equity stake in the Samsung Bioepis joint venture to partner Samsung Biologics.  On April 20, 2022, Samsung Biologics and Biogen announced that Samsung Biologics has now fully acquired Samsung Bioepis for a total consideration of USD…

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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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FDA Accepts Samsung Bioepis’ and Organon’s sBLA for their Citrate-Free, High-Concentration HUMIRA (Adalimumab) Biosimilar Candidate

Last week, Samsung Bioepis Co., Ltd. and Organon & Co. announced that the FDA accepted for review their supplemental Biologics License Application (sBLA) for a citrate-free, high-concentration (100 mg/mL) formulation of SB5 (adalimumab-bwwd), a biosimilar referencing HUMIRA (adalimumab). The FDA previously approved SB5 under the brand name HADLIMA as a low-concentration…

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Year in Review: Top-Five U.S. Biosimilar Market Developments of 2021

As we ring in the new year, we look back at the top U.S. biosimilar market developments of 2021. Here are our top five: 1. SEMGLEE Launches As First-Ever Interchangeable Biosimilar In July, the FDA approved Viatris Inc.’s (formerly Mylan Pharmaceuticals Inc.) SEMGLEE (insulin-glargine-yfgn), a biosimilar to LANTUS (insulin glargine)….

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