by April Breyer Menon | Apr 4, 2026
On April 2, 2026, Biocon filed a petition for post-grant review (“PGR”) challenging Regeneron’s U.S. Patent No. 12,168,036 (“the ’036 patent”), which is directed to methods for treating angiogenic eye disorders using high doses of VEGF receptor fusion proteins. The...
by April Breyer Menon | Apr 1, 2026
On March 31, 2026, Amgen reached a settlement with Shanghai Henlius Biotech, resolving BPCIA litigation No. 1:25-cv-12160 (D.N.J.) / 1:25-md-03138 (D.N.J.) concerning Prolia® / Xgeva® (denosumab) biosimilars Bildyos® / Bilprevda® (denosumab-nxxp). This is the eighth...
by April Breyer Menon | Mar 31, 2026
On March 30, 2026, Teva announced that the FDA and the European Medicines Agency (EMA) accepted regulatory submissions for its proposed biosimilar to Xolair® (omalizumab), TEV-45779. The submissions include a Biologics License Application (BLA) to the FDA and a...
by April Breyer Menon | Mar 31, 2026
On March 30, 2026, the FDA approved Teva’s biosimilar Ponlimsi™ (denosumab-adet), referencing Amgen’s Prolia® (denosumab), for all indications of the reference product. Ponlimsi™ is the tenth Prolia® / Xgeva® (denosumab) biosimilar approved by the FDA....
by April Breyer Menon | Mar 31, 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...
