by April Breyer Menon | Aug 5, 2026
On August 3, 2026, Fresenius Kabi and Dr. Reddy’s announced the FDA-approval of Zimrixby™ (rituximab-cdxx), a biosimilar of Genentech’s Rituxan® (rituximab). Zimrixby™ is the fourth Rituxan® biosimilar approved in the U.S. Truxima® (rituximab-abbs) was...
by April Breyer Menon | Aug 3, 2026
Changes at the Patent Trial and Appeal Board (“PTAB”) since early 2025 have significantly altered the landscape for patent challenges in a more pro-patent direction, with control of proceedings increasingly centralized with the U.S. Patent and Trademark Office (“PTO”)...
by April Breyer Menon | Aug 2, 2026
On July 31, 2026, Fresenius Kabi and Polpharma announced the FDA acceptance of their aBLA for PB016 (vedolizumab), a proposed intravenous biosimilar of Takeda’s Entyvio® (vedolizumab). They also announced the acceptance of their Marketing Authorisation Application...
by April Breyer Menon | Jul 31, 2026
On July 29, 2026, Genentech filed BPCIA litigation No. 2:26-cv-09585 (D.N.J.) against Biocon’s proposed Perjeta® (pertuzumab) biosimilar Bmab 1500. Genentech asserted 28 patents, including 14 with manufacturing claims, 11 with method of treatment claims, four with...
by April Breyer Menon | Jul 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...
