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...
by April Breyer Menon | Mar 29, 2024
In an interview with the Center for Biosimilars, Venable’s Ha Kung Wong discusses concerns about “bad patents” hindering biosimilar access, but assures that the FDA and United States Patent and Trademark Office are working to improve the system. He...
by April Breyer Menon | Mar 21, 2024
On March 13, 2024, Regeneron appealed the PTAB Board’s (“the Board”) recent Final Written Decisions (“FWDs”) that found claims of two Regeneron patents related to EYLEA® (aflibercept) unpatentable. In CAFC 24-1564 Regeneron appeals the Board’s FWD in IPRs brought by...