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.

Latest from Big Molecule Watch - Page 10

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

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