ImmuNext`s Biologic Enbrel (etanercept) Receives Approval in the U.S.
Amgen breathed a sigh of relief this summer when the Supreme Court ndeclined to take up a Sandoz patent dispute challenging its nanti-inflammatory blockbuster Enbrel. Now, the California drugmaker has nwarded off a second would-be rival, securing monopoly sales for many nyears to come.
On January 21, Genentech filed a reply brief in its appeal to the Federal Circuit seeking to overturn the district court’s denial of Genentech’s motion to enjoin the U.S. marketing of MVASI (bevacizumab-awwb), a biosimilar of AVASTIN. As we previously reported, Genentech’s opening brief argued that although Amgen served a notice of commercial marketing pursuant to subsection (l)(8)(A) of the BPCIA in 2017, Amgen was required to provide a new notice because it subsequently filed supplements to its approved biosimilar application. Genentech argued in its reply brief that because Amgen failed to provide a second notice, Amgen was legally barred from commercially marketing its biosimilar until 180 days after it served such notice. Oral argument has not yet been set.