On April 26, 2017, the U.S. Supreme Court heard oral argument in the much-anticipated Amgen v. Sandoz case, representing the first time the Court has had to grapple with the Biologics Price Competition and Innovation Act (“BPCIA”) since this key law went into effect in 2010. The BPCIA created a new, abbreviated pathway for highly similar biological products to enter the U.S. market by following in the footsteps of a reference biological product. The Court’s decision, which should issue in June, will be closely watched by participants in the pharmaceutical, biotech, and health care sectors.
The case arose from Sandoz’s filing for and subsequent approval and launch of Zarxio (filgrastim-sndz), a biosimilar version of Amgen’s G-CSF product Neupogen (filgrastim). Zarxio was the first biosimilar approved under the BPCIA’s abbreviated pathway. The parties’ cross-petitions for Supreme Court review arose from a fractured July 2016 Federal Circuit decision and involved two distinct issues:
- Sandoz’s petition: Whether, in order to be effective, the 180-day pre-launch notice required under 42 U.S.C. § 262(l)(8)(A) may be given by a biosimilar applicant to the reference product sponsor only after the FDA has licensed the biosimilar product.
- Amgen’s cross-petition: Whether one of the BPCIA’s key information exchange provisions – specifically, 42 U.S.C. § 262(l)(2)(A), which governs disclosure of the biosimilar application to the reference product sponsor – is mandatory or optional, and what the consequences of non-compliance with or “opting out” of this exchange provision should be.
In its decision below, the Federal Circuit had labeled the reticulated structure of the BPCIA as “a riddle wrapped in a mystery inside an enigma.” Amgen v. Sandoz, 794 F.3d 1347, 1351 n.1 (Fed. Cir. 2015). Yesterday’s argument did little to dispel that notion.
On the 180-day notice issue, also referred to during argument as the “8(A)” issue, the Justices focused their questions on how FDA approval of biosimilars works in practice; how long the approval process takes; and whether it would be possible for FDA to issue some form of preliminary approval, but not an “effective” approval, prior to the end of the reference biologic’s 12-year exclusivity period. This latter issue had been flagged by the Federal Circuit below, even though the BPCIA does not expressly provide for such preliminary approval (often called “tentative” approval when granted by FDA in the Hatch-Waxman small-molecule context). Some of the Justices expressed concern that the Court was being asked to answer key policy questions – involving complex drugs and their equally complex approval scheme – without the benefit of any agency opinion, guidance, or regulations on the topic.
On the information exchange issue, also referred to during argument as the “2(A)” issue, the Justices asked questions regarding the interplay of rights and remedies both internal and external to the BPCIA. They also queried whether federal-state preemption was an issue they could fairly avoid in deciding the case. The Federal Circuit had not relied on preemption for its decision and the parties had consequently not highlighted it in their briefing. Nevertheless, considerable discussion was focused on what the Court should do with the fact that Amgen’s original complaint sought relief not simply under federal patent law or the BPCIA, but also under California state law (pinning such state-law relief on Sandoz’s alleged violation of the BPCIA).
None of these are easy questions, and no clear answers were signaled by the Court. But because all stakeholders have an interest in the basic rules of the road, the implications of any decision on the nascent U.S. biosimilars market should not be underestimated. We will provide further commentary when the Court issues a decision.