by April Breyer Menon | Mar 12, 2026
On March 9, 2026, the FDA updated its guidance addressing biosimilar development under the Biologics Price Competition and Innovation Act (BPCIA) (“New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4)”). These updates follow the FDA’s...
by April Breyer Menon | Mar 10, 2026
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by April Breyer Menon | Mar 6, 2026
On March 3, 2026, Janssen filed a Complaint in the U.S. District Court for the District of Delaware against Accord and Bio-Thera Solutions, Case No. 1:26-cv-00222 (D. Del.), initiating the first BPCIA litigation related to Janssen / Johnson &...
by April Breyer Menon | Mar 2, 2026
On February 27, 2026, Genentech filed a complaint under Section 337 of the Tariff Act of 1930 with the U.S. International Trade Commission (ITC) against Biocon concerning its proposed Perjeta® (pertuzumab) biosimilar, BMAB 1500 / PERT-IJS. Genentech seeks a permanent...
by April Breyer Menon | Feb 28, 2026
Download PDF *Denosumab Challenged Claim Types in Litigation: Claims are counted in each litigation, so claims from the same patent challenged in multiple litigations are counted more than once. Within each litigation a claim is counted...