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
Big Molecule Watch
Big Molecule Watch, published by Goodwin Procter, focuses on legal developments related to biologic drugs, biosimilars, and complex pharmaceutical products. The blog covers regulatory approvals, patent litigation, and market entry strategies for biosimilars and innovative biologic therapies. It reports on FDA and European Medicines Agency decisions, patent settlements, and industry trends affecting the life sciences sector. Topics include biosimilar launches, regulatory compliance, intellectual property disputes under the Biologics Price Competition and Innovation Act (BPCIA), and advancements in cell and gene therapies. The blog serves as a resource for legal professionals and industry stakeholders tracking the evolving landscape of biologic medicines.
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Celltrion and Sandoz Launch Their Aflibercept Biosimilars in Europe
On November 27, 2025, Celltrion announced that Health Canada approved EYDENZELT® (aflibercept-boav), a biosimilar referencing Regeneron’s EYLEA® (aflibercept), in both vial and pre-filled syringe form, to treat all indications approved for EYLEA®. EYDENZELT® is Celltrion’s first biologic product approved in…
Sun Pharma Launches ILUMYA® in India
On December 1, 2025, Sun Pharmaceutical Industries Ltd. (“Sun Pharma”) announced the launch of ILUMYA® (tildrakizumab-asmn) in India. ILUMYA® is a humanized monoclonal antibody injection indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic…
FDA Approves mAbxience and Amneal’s Denosumab Biosimilars
On December 22, 2025, the FDA approved mAbxience and Amneal’s Biologics Licensing Applications (BLAs) for BONCRESA (denosumab-mobz) and OZILTUS (denosumab-mobz), biosimilars referencing Amgen’s PROLIA® (denosumab) and XGEVA® (denosumab), respectively. Under Amneal’s partnership with mAbxience, mAbxience is responsible for development and…
Biocon and Regeneron Enter Global Settlement on Aflibercept Biosimilar
On December 13, 2025, Biocon Biologics Ltd. (“Biocon”) and Regeneron Pharmaceuticals, Inc. (“Regeneron”) entered into a license and settlement agreement to dismiss all pending claims in the parties’ disputes over Biocon’s aflibercept biosimilar, YESAFILI® (aflibercept-jbvf) in Europe and the rest…
CareFirst’s Class Action STELARA® Antitrust Case Against J&J Will Proceed: Court Grants-in-Part and Denies-in-Part Class Certification and Denies the Parties’ Motions for Summary Judgment
As we have previously reported, a group of health insurers and health insurance administrators (collectively, “CareFirst”) filed a class action complaint in 2023 against Johnson & Johnson and Janssen Biotech, Inc. (collectively, J&J), alleging multiple violations of federal and…
Regeneron Seeks to Bifurcate or Stay Amgen’s Antitrust Claims in Aflibercept Patent Litigation
On December 11, 2025, Regeneron filed a Memorandum in Support of Its Motion to Bifurcate and Stay Amgen’s Antitrust Claims in the ongoing aflibercept patent litigation in the U.S. District Court for the Northern District of West Virginia.
As we…
Vertex Presents New CASGEVY® Data in Patients 5-11 Years and Announces Plan for Global Regulatory Submissions
On December 6, 2025, Vertex Pharmaceuticals Inc. (“Vertex”) announced data from several studies demonstrating the clinical benefits of CASGEVY® (exagamglogene autotemcel), including, for the first time, clinical data from studies in children ages 5-11 years. CASGEVY® is a non-viral, ex-vivo…
FDA Approves New Dose for Celltrion’s OMLYCLO (omalizumab-igec)
On December 3, 2025, Celltrion announced that the FDA has approved a new dose of OMLYCLO (omalizumab-igec), the first and only biosimilar designated as interchangeable with Genentech and Novartis’s XOLAIR (omalizumab). The FDA approved a 300 mg/2mL solution of OMLYCLO…
European Biosimilar Updates – Six Denosumab Launches and Positive Opinion for Samsung Bioepis’s BYOOVIZ
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
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