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
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
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
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
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
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
12/17/2021
/ Administrative Procedure Act ,
Admissible Evidence ,
Evidence ,
Ex Partes Reexamination ,
Federal Rules of Evidence ,
Final Written Decisions ,
Forum Selection ,
Intellectual Property Protection ,
Inter Partes Review (IPR) Proceeding ,
Motion to Amend ,
Motion to Exclude ,
Non-Disclosure Agreement ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
USPTO
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
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