On June 2, 2026, Chime Biologics and Daewoong Pharmaceutical announced a strategic partnership agreement for the development and manufacturing of a dupilumab biosimilar candidate referencing Sanofi and Regeneron’s DUPIXENT.
Chime Biologics is a global CDMO headquartered in China and with
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BIOSECURE Update – 1260H List Released
The Department of Defense has published its updated Section 1260H list of “Chinese military companies” this week, and WuXi AppTec along with 27 other new entities were identified on the list. (Federal Register notice available here: https://public-inspection.federalregister.gov/2026-11571.pdf.) DoD
Boan Biotech Submits BLA to FDA for Two Denosumab Biosimilars
On May 29, 2026, Boan Biotech announced that it submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for BA6101 (denosumab; injection 60 mg) and BA1102 (denosumab; injection 120 mg), referencing Amgen’s PROLIA® (denosumab) and
Polpharma and Tuteur Enter License for the Commercialization of a Biosimilar Targeting Autoimmune Diseases in Latin America
On May 22, 2026, Polpharma Biologics announced that it had entered into an exclusive licensing agreement with Tuteur to commercialize a biosimilar targeting autoimmune diseases across Latin America, excluding Brazil. The parties did not disclose which specific biosimilar is covered
Samsung Bioepis Launches OPUVIZ in Europe
On May 29, 2026, Samsung Bioepis Co., Ltd. announced the European launch of OPUVIZ, a biosimilar referencing EYLEA (aflibercept). OPUVIZ will be available as a 40 mg/mL solution for injection.
Commenting on the launch, Antonio Rito, Vice President and Head
Amneal and Kashiv File IPR Petition on Omalizumab Patent
On May 26, 2026, Amneal Pharmaceuticals, Inc. and Kashiv Biosciences petitioned for inter partes review (IPR2026-00260) of all claims of U.S. Patent No. 12,030,959 (“the ’959 patent”), assigned to Novartis AG and Genentech, Inc. The ’959 patent is generally directed
Public Company Advisory News Roundup: SEC Proposes Significant Changes to the Registered Offering Framework
The latest issue of the Goodwin Public Company Advisory News Roundup has been posted, covering the period from May 11, 2026 – May 21, 2026. The Roundup highlights the latest developments in SEC and stock exchange regulatory activity, corporate governance