On February 11, 2026, Formycon AG and Lotus Pharmaceutical announced the execution of an exclusive license agreement directed to Formycon’s pembrolizumab biosimilar candidate, FYB206. Pembrolizumab is currently approved as KEYTRUDA (Merck Sharp & Dohme LLC) and is indicated to treat a variety of tumors. FYB206 is near the end of…
On February 11, 2026, Samsung Bioepis, Co., Ltd (“Samsung”) and Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed a Joint Stipulation and Proposed Order seeking to dismiss all claims and counterclaims without prejudice and to vacate the preliminary injunction previously entered against Samsung. According to Regeneron, the parties entered into a settlement agreement…
On January 11, 2026, the FDA issued two news releases putting forward reforms to the chemistry, manufacturing, and control requirements for cell and gene therapy products, one titled FDA Increases Flexibility on Requirements for Cell and Gene Therapies to Advance Innovation and the other titled Flexible Requirements for Cell and…
On January 19, 2026, Hikma announced the U.S. launch of ENOBY (denosumab-qbde) and XTRENBO (denosumab-qbde)—denosumab biosimilars referencing Amgen’s PROLIA and XGEVA, respectively. As recited in the announcement, “[d]enosumab is indicated for treating osteoporosis in postmenopausal women, preventing skeletal-related complications in cancer that has spread to the bone, and treating unresectable giant cell tumor of…
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….
On January 12, 2026, Sanofi announced that the European Commission approved its Teizeild (teplizumab) for delaying progression to stage 3 type 1 diabetes (“T1D”) in adults and children eight years and older who have stage 2 T1D. Teizeild marks the first disease-modifying treatment for T1D available in the EU. Sanofi…
In a new draft guidance issued on January 14, 2026, the FDA discussed the use of a modern statistical methodology in clinical trials designed to show the effectiveness of a new drug. The guidance, “Use of Bayesian Methodology in Clinical Trials of Drugs and Biologics Guidance for Industry,” outlines how…
On January 12, 2026, AbbVie and RemeGen announced an exclusive licensing agreement granting AbbVie rights to develop, manufacture, and commercialize RemeGen’s RC148 outside of Greater China. In exchange, RemeGen will receive a $650 million upfront payment, with the potential for up to $4.95 billion in milestone payments, including tiered, double-digit…
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…
As we head into what is anticipated to be a strong year for biopharma dealmaking, we look back at some of the biggest deals in 2025 that focus on biologics and biosimilars. Antibody Therapy Deals Novartis acquires Avidity Biosciences On October 26, 2025, Novartis AG and Avidity Biosciences, Inc. announced…