by April Breyer Menon | Apr 23, 2024
According to an April 2024 press release, Alvotech and Teva’s Selarsdi™ (ustekinumab-aekn) was approved by the FDA on April 16 as a biosimilar of Janssen / Johnson & Johnson’s Stelara® (ustekinumab). The companies announced in June 2023 that they had...
by April Breyer Menon | Apr 23, 2024
In an interview with the Center for Biosimilars, Venable’s Ha Kung Wong explores the challenges of “patent thickets” in the biologics market, where a complex web of patents can hinder development of more affordable biosimilar drugs. The discussion...
by April Breyer Menon | Apr 17, 2024
On April 12, 2024, the Federal Circuit dismissed CAFC Appeal No. 24-1402 and Cross-Appeal No. 24-1405 for lack of jurisdiction following its February 22, 2024 order directing Regeneron and Mylan / Biocon to show cause why the appeals of the District Court’s December...
by April Breyer Menon | Apr 15, 2024
On April 10, 2024, the Court granted Plaintiffs Genentech, Hoffmann-La Roche, and Biogen and Defendants Dr. Reddy’s and Fresenius Kabi’s joint stipulation of dismissal due to settlement in Case No. 1:23-cv-22485 (D.N.J.) related to Dr. Reddy’s and Fresenius...
by April Breyer Menon | Apr 10, 2024
In an interview with the Center for Biosimilars, Venable’s Ha Kung Wong discusses the advantages of the BPCIA patent dance in answering the question, “What are the key objectives of the patent dance, and how does it contribute to streamlining the exchange...