The Supreme Court on Jan. 25 laid out the schedule for Amgen Inc. and rival Sandoz to submit briefs in their battle over the interpretation of the U.S. biosimilars law, the Biologics Price Competition and Innovation Act.
The schedule sets the stage for the oral arguments in the landmark case to likely be heard in late April, with a decision by the end of June.
The high court revealed on Jan. 13 that it would take up the case, in which Amgen and Sandoz, a unit of Novartis AG, are fighting over the meaning of certain provisions of the BPCIA — the law that empowered the FDA to approve biosimilars, which are intended to be lower-cost versions of biological medicines.
The Supreme Court is being asked to decide how soon a biosimilar should be permitted to enter the U.S. market after it is approved and if manufacturers of those products should provide a copy of their applications and other details to the innovator companies.
The case is the first time the Supreme Court is addressing issues involving biosimilars or the BPCIA, a complicated law that one appeals judge described as a "riddle wrapped in a mystery inside an enigma" — a phrase he borrowed from former U.K. Prime Minister Winston Churchill.
The lawsuit involves Sandoz's Zarxio, a biosimilar version of Amgen's Neupogen, a leukocyte growth factor used to treat the depletion of white blood cells caused by cancer.
Zarxio was the first biosimilar to be approved by the FDA, which granted its blessing in March 2015 for Sandoz to sell the product. But because of the lawsuit, it could not enter the U.S. market until six months later, in September 2015.
The Supreme Court wants Sandoz to submit its opening brief by Feb. 10, with Amgen's response due by March 10. Sandoz will then have an opportunity to respond, which it must do by March 31. The justices gave Amgen until April 14 to reply.
In addition to setting the timeline for Amgen and Sandoz to present their cases on paper, the court's schedule also discloses when the justices will accept amici, or "friend of the court" briefs, from interested parties who are not involved in the lawsuit, but who wish to provide their perspective.
The amici are intended to educate the court and help it gain insight into how a ruling may affect and have implications for parties beyond those involved directly in the lawsuit.
The Supreme Court called for those parties supporting Sandoz to submit their briefs by Feb. 17, while entities backing Amgen have until March 17.
Among those who weighed in with amici when the Supreme Court was considering whether to wade into the BPCIA matter was Pfizer Inc. unit Hospira, which is marketing Inflectra, a biosimilar version of Johnson & Johnson's Remicade. Inflectra is the only other biosimilar besides Zarxio currently on the U.S. market, even though there are two others approved — Sandoz's Erelzi and Amgen's Amjevita.
Novartis revealed in its Jan. 25 earnings report that Sandoz was being forced to delay market entrance of Erelzi because of a lawsuit with Amgen, which markets the brand-name version, Enbrel.
Hospira, along with Mylan NV, which also submitted an earlier amicus brief, sided with Sandoz in arguing Congress did not intend for market entrance of biosimilars to be delayed by an additional six months after approval and that it was lawmakers' overriding goal to expedite access to those lower-cost medicines.
The acting U.S. solicitor general for the Obama administration also agreed with that position in a December 2016 brief and urged the Supreme Court to back Sandoz's arguments over Amgen's.