by April Breyer Menon | Apr 10, 2024
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by April Breyer Menon | Apr 2, 2024
On March 27, 2024, the PTAB summarily denied Seagen’s February 14, 2024 request for Director Review of the PTAB’s January 16, 2024 Final Written Decision (“FWD”) in PGR2021-00030 related to Adcetris® (brentuximab vedotin). In the FWD, the PTAB held that the...
by April Breyer Menon | Mar 31, 2024
On March 10, 2024, Celltrion announced in a press release that it submitted an abbreviated Biologics License Application (aBLA) for FDA approval of CT-P39 (omalizumab), a proposed interchangeable biosimilar of Genentech’s / Novartis’ Xolair® (omalizumab). This is the...
by April Breyer Menon | Mar 29, 2024
In an interview with the Center for Biosimilars, Venable’s Ha Kung Wong discusses lawsuits by drug companies aimed at delaying competition from biosimilars, including those involving Humira® (adalimumab) and Remicade® (infliximab) biosimilars, and the recent...
by April Breyer Menon | Mar 29, 2024
In an episode of the “Not so Different” podcast with the Center for Biosimilars, Venable’s Ha Kung Wong details the confusing landscape that is the U.S. patent system and how it can be improved to help companies overcome barriers to biosimilar...