Supreme Court to review key biosimilar dispute
- The Supreme Court last week agreed to review a dispute between drugmakers Amgen and Novartis' Sandoz unit over the process for launching a biosimilar version of a branded biologic, setting the stage for an important ruling later this year.
- At issue are key provisions of the Biologics Price Competition and Innovation Act (BPCIA) which govern when a biosimilar developer needs to give notice to branded drugmakers of its intent to sell a biosimilar, which are highly similar, copycat versions of pricey biologic drugs.
- While the legal details are technical, the case will set an important precedent for the emerging field and could clarify how biosimilars are brought to market.
The BPCIA stipulates that biosimilar applicants need to provide the relevant branded drugmaker with 180 days notice of commercial marketing. Amgen and Sandoz, which makes a biosimilar version of Amgen's Neupogen (filgrastim), have been squabbling over whether this notice must be given before or after the Food and Drug Administration approves the biosimilar.
In 2015, a federal appeals court in 2015 sided with Amgen, ruling the 180-day clock only begins after FDA approval. While six months may appear trivial, that extra time gives the branded drugmaker another half-year's worth of exclusive sales, as well as a lengthier timeframe in which to defend its patents.
Sandoz appealed, however, bumping the case to the Supreme Court, which has now granted certiorari and will likely hear oral arguments this year.
The Supreme Court's decision follows a recommendation last month from the U.S. Solicitor General to take up consideration of Sandoz v. Amgen. The Solicitor General disagreed with the federal appeals court's decision, arguing notice of marketing before FDA approval was consistent with the BPCIA.
The case also involves whether biosimilar drugmakers are required to disclose a copy of a biosimilar application and information about its manufacturing processes to the branded drugmaker — a process known as the "patent dance."
When Sandoz applied for approval of its biosimilar Zarxio (filgrastim-sndz), it declined to provide this material to Amgen, arguing the process wasn't mandatory. The appeals court actually agreed with Sandoz on this issue, but ruled that doing so would open a company to patent-infringement action from the brand-name drugmaker.
According to the Big Molecule Watch blog from lawyers at GoodwinProctor, the case is expected to be argued in April and decided as early as the end of June.
This post is part of a series focused exclusively on biosimilars. To view other posts in the series, check out the spotlight page.
- Supreme Court Order
- Solicitor General Amicus brief
- Big Molecule Watch Analysis of Solicitor General's brief in Sandoz v. Amgen
Follow Ned Pagliarulo on Twitter