by April Breyer Menon | May 7, 2026
On April 29, 2026, the U.S. Food and Drug Administration (FDA) approved Sunshine Lake Pharma’s Langlara™ (insulin glargine-aldy) biosimilar to Sanofi’s Lantus® (insulin glargine), for the treatment of adult and pediatric patients with type 1 diabetes and adults...
by April Breyer Menon | Apr 20, 2026
On April 16, 2026, the U.S. Court of Appeals for the Federal Circuit reversed the district court’s judgment as a matter of law (“JMOL”) finding Teva’s asserted patent claims invalid for lack of written description and enablement in Teva Pharmaceuticals v. Eli Lilly...
by April Breyer Menon | Apr 9, 2026
On April 7, 2026, Biocon announced the U.S. commercial launch of Bosaya™ / Aukelso™ (denosumab-kyqq), biosimilars of Amgen’s Prolia® / Xgeva® (denosumab). Both products were approved by the U.S. Food and Drug Administration in September 2025 and were...
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...
