Supreme Court takes up Amgen, Sandoz's market-defining biosimilars dispute

The U.S. Supreme Court will take on a closely watched legal skirmish between Amgen and Novartis’ Sandoz, with the outcome set to define launch timelines across the budding biosim field.

The Supreme Court says it will hear a case centering on particular provisions of the Biologics Price Competition and Innovation Act (BPCIA), which created a regulatory pathway for biosimilar drugs. At issue is a six-month waiting period required after a biosim company notifies the original developer about its would-be rival drug—and when, exactly, that notification can take place.

A federal appeals court had previously ruled that biosim companies must have an FDA approval in hand before they can officially notify of a launch. Sandoz argues that the court's interpretation creates an “exclusivity windfall” for the originator company that Congress did not intend to grant. The company says biosim makers should be able to provide that notice earlier in the development process.

Sandoz, which launched a biosimilar version of Amgen’s Neupogen back in 2015 after a legal war—and after waiting out exactly that type of delay—asked the Supreme Court to get involved early last year with the hope that it would interpret the "patent dance" provisions differently for future launches.

That’s a desire shared by other companies developing biosimilar versions of the world’s top drugs. In a friend-of-the-court filing in the Amgen v. Sandoz case, Pfizer’s Hospira and partner Celltrion contended that a Supreme Court review is “needed to prevent pointless, 180-day injunctions” that aren’t tied to patent claims. The companies said a lower court “offered no congressional rationale” for the ruling in Amgen’s favor.

Before it committed to hearing the two companies' arguments, SCOTUS invited the Obama Administration to weigh in. The solicitor general then recommended the court take up the issue.

With its decision to consider the case, the high court will take its first shot at deciphering the BPCIA law. The eventual ruling will ripple through the biopharma industry, as biosimilar companies work to push their products through and many top drugmakers face biosim pressure in the coming years.

The stakes are high for Novartis, which won FDA approval last August for its second biosim, a copy of Amgen’s anti-TNF blockbuster Enbrel. The company is looking to launch five biosimilars by 2020.