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Updates on Patent Challenges by Biosimilar Manufacturers at the PTAB

In the last month, there has been a flurry of activity at the PTAB related to challenges from biosimilar manufacturers related to ustekinumab, aflibercept, and eculizumab patents. 1. STELARA® (ustekinumab) Four months after Janssen Biotech, Inc. settled to terminate Samsung Bioepis Co., Ltd.’s inter partes review (IPR) challenge of U.S….

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Recent Biosimilar Commercialization Developments

Insulin Biosimilars: Meitheal Pharmaceuticals, Inc. has announced an exclusive licensing agreement with Tonghua Dongbao Pharmaceuticals Co., Ltd. to commercialize Tonghua Dongbao’s three insulin biosimilars (insulin aspart, insulin lispro, and insulin glargine) in the U.S. market.  Meitheal and Tonghua Dongbao will be jointly responsible for development and supply, with the expectation…

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FDA Approves Regeneron’s 8 mg injection of EYLEA (aflibercept) and VEOPOZ (pozelimab)

Bottle of Pills and a FDA APPROVED rubber stamp

On August 18, 2023, Regeneron Pharmaceuticals, Inc. (“Regeneron”) announced that the FDA approved EYLEA HD®, an 8 mg injection of EYLEA® (aflibercept).  EYLEA HD®, jointly developed with Bayer A.G., is approved for the treatment of wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy (DR).  EYLEA® was…

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