On October 14, 2026, the U.S. District Court for the District of New Jersey entered an order dismissing without prejudice all claims in Genentech Inc. and Hoffmann-La Roche Inc.’s BPCIA litigation against Biocon Biologics Inc. concerning its proposed pertuzumab biosimilar. The same day, Biocon announced that it had entered into a…
On October 5, 2026, Celltrion USA announced that OMLYCLO® (omalizumab-igec) is commercially available in the United States. OMLYCLO® is the first and only FDA-approved interchangeable biosimilar to Genentech and Novartis’s XOLAIR® (omalizumab). As we previously reported, the FDA approved the anti-IgE antibody in March 2025 for all four XOLAIR® indications: moderate…
On July 29, 2026, Genentech, Inc. (“Genentech”) and Hoffmann-La Roche Inc. filed a complaint in the U.S. District Court for the District of New Jersey against Biocon Biologics Inc. (“Biocon”) and related entities, alleging infringement of 28 patents relating to Genentech’s PERJETA and Biocon’s proposed biosimilar, Bmab1500. As we previously…
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 to methods for treating pediatric patients having food allergies by…
On February 27, 2026, Genentech filed a Section 337 complaint at the U.S. International Trade Commission (ITC) targeting Biocon’s proposed pertuzumab biosimilar, BMAB 1500/PERT-IJS, which references Genentech’s PERJETA®. The complaint, captioned Certain Pertuzumab Biosimilars, Including Those Made by Certain Methods of Manufacturing, the Active Ingredient Thereof, and Products Containing the…
On January 30, 2026, the U.S. District Court for the District of New Jersey entered a Joint Stipulation of Dismissal resolving the pertuzumab BPCIA litigation between Genentech, Inc. and Hoffmann-La Roche Inc. (together, “Genentech”) and Shanghai Henlius Biotech, Inc., Shanghai Henlius Biologics Co., Ltd., Organon LLC, and Organon & Co….
This past year contained a number of significant developments in litigation involving biologics and biosimilars. The following is a recap of the top three legal developments that we covered on the Big Molecule Watch last year. The Aflibercept BPCIA Litigations Start to Resolve As in 2023 and 2024, Regeneron’s multi-district…
Just in December, six companies have announced the launch of their denosumab biosimilars in Europe: Sandoz, Samsung Bioepis, Fresenius Kabi, Zentiva, Biocon Biologics, and Accord. On December 1, 2025: Sandoz launched its denosumab biosimilars, WYOST (120 mg) and JUBBONTI (60 mg) in Europe. WYOST is approved for the treatment of…
On November 12, 2025, Sandoz announced a licensing agreement with EirGenix to commercialize EG1206A (pertuzumab), a proposed biosimilar of Genentech’s PERJETA® (pertuzumab). Under the terms of the agreement, Sandoz has exclusive worldwide commercial rights to the product, excluding certain countries in Asia, while EirGenix is responsible for development, manufacturing, and…
On November 13, 2025, the FDA approved Shanghai Henlius Biologics Co. Ltd.’s POHERDY (pertuzumab-dpzb) as an interchangeable biosimilar to Genentech’s PERJETA (pertuzumab). This is the first pertuzumab biosimilar to receive FDA approval. Pertuzumab is a HER2 inhibitor that is administered via an intravenous infusion with other agents and chemotherapies. POHERDY…