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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...more

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...more

International Biosimilar Approval and Launch Updates - February 2022

Samsung Bioepis Co. Ltd. announced that Health Canada approved ONTRUZANT (also known as SB3), a biosimilar referencing Herceptin (Trastuzumab), for the treatment of adults with Early Breast Cancer, Metastatic Breast Cancer...more

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

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...more

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...more

Issue 36: PTAB Trial Tracker

FORUM SELECTION CLAUSES MAY OR MAY NOT PRECLUDE PTAB REVIEW - In Kannuu Pty Ltd. v. Samsung Electronics Co., Ltd. & Samsung Electronics America, Inc., No. 21-1638 (Fed. Cir. Oct. 7, 2021), the Federal Circuit considered...more

International Biosimilar Approval and Launch Updates

On November 25, 2021, Japan-based Mochida Pharmaceutical Co. announced that its adalimumab biosimilar, Adalimumab BS MA, had been launched in Japan following the listing of the drug on the National Health Insurance. According...more

Express Scripts Adds Biosimilar SEMGLEE to Preferred Formulary

In October, Express Scripts announced that it would add Viatris’ SEMGLEE (insulin glargine-yfgn) injection as a preferred therapy on its formulary beginning in January 2022. Back in July, the FDA approved SEMGLEE as the first...more

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