On Friday, in the ongoing Amgen v. Hospira district court litigation regarding Hospira’s proposed biosimilar of Epogen®/Procrit® (epoetin alfa), Amgen filed a motion for preliminary injunction seeking to enjoin Hospira from launching its biosimilar “until Hospira has complied with the requirement of 42 U.S.C. § 262(l)(8)(A), which states that ‘[t]he subsection (k) applicant shall provide notice to [Amgen] not later than 180 days before the date of the first commercial marketing of the biological product licensed under subsection (k).’” Amgen asserts that it “has made a reasonable effort to reach agreement with Hospira on the subject matter set forth in this Motion, and the parties have been unable to reach agreement.” The specific grounds for the motion are laid out in an accompanying brief and declarations, all of which were filed under seal and which are not yet publicly available in redacted form. This preliminary injunction motion comes on the heels of the Oncologic Drugs Advisory Committee’s recommendation last week that FDA approve Hospira’s proposed biosimilar across all indications. As we’ve reported on extensively, the statutorily permitted timing of a biosimilar applicant’s notice of first commercial marketing under subsection (l)(8)(A) is one of the questions presented in the pending dispute before the U.S. Supreme Court, which heard oral argument last month and is expected to issue a decision within the next month.
We will continue to monitor this litigation in the district court, as well as at the Federal Circuit, which heard oral argument on the parties’ discovery dispute about two months ago and could issue its decision at any time. Stay tuned to Big Molecule Watch for further updates.