by April Breyer Menon | Aug 26, 2026
On August 13, 2026, the FDA (Center for Drug Evaluation and Research (“CDER”) and Center for Biologics Evaluation and Research (“CBER”)) issued final guidance addressing formal meetings between the FDA and sponsors or applicants relating to the development and review...
by April Breyer Menon | Aug 12, 2026
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by April Breyer Menon | Aug 6, 2026
On August 3, 2026, Biocon announced the launch of Yesafili™ (aflibercept-jbvf), an interchangeable biosimilar of Regeneron’s EYLEA® (aflibercept), after FDA-approval in May 2024. Yesafili™ was initially under a permanent injunction after numerous claims...
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”)...