- The Supreme Court has invited the Obama administration to weigh in on an important case between Amgen and Sandoz, the generics unit of Novartis, over when a biosimilar can be marketed.
- At issue in the case is a provision of the Biologics Price Competition and Innovation Act which stipulates that biosimilar makers must give 180 days notice to the brand-name company before launching a copy on the market.
- Sandoz argues it should be able to provide notice 180 days before the FDA approves a drug, but an appeals court ruled last year that companies have to wait until an approval decision is actually made.
While the 6-month window may seem a small blip in the overall lifespan of a drug, there is a lot at stake, both for the companies involved and for the growing market for biosimilars in the U.S.
Requiring a biosimilar company to wait 6 more months before marketing their copy of a branded biologic gives the original drugmaker more time to sell its drug. But perhaps more importantly, the original drugmaker has an additional 6 months to prepare legal challenges and additional patent hurdles to obstruct the entry of a biosimilar.
Some backstory: Sandoz won approval for Zarxio, a biosimilar version of Amgen's Neupogen last year. Sandoz had argued it could give notice 180 days before the FDA was scheduled to decide on Zarxio's approval. An appeals court ruled in favor of Amgen, but Sandoz appealed, pushing the case to the Supreme Court.
The Supreme Court has now invited the Solicitor General to file a brief in the case expressing the view of the Obama administration.
Writing in a blog post, lawyers at the patent law firm Fish & Richardson indicated the Supreme Court's request would likely delay any movement in the case until October at the earliest.
The case comes at a time when the fledgling biosimilars industry in the U.S. has begun to grow. The FDA has approved two biosimilars, Novartis' Zarxio (at issue in this case) and Celltrion/Pfizer's Inflectra.
A number of other biosimilars are currently awaiting an FDA decision and several companies are pushing further development.
All of this makes a decision by the Supreme Court more important. If the Court issues a ruling, it would set a precedent impacting the time to market for future biosimilars.
Biosimilars are expected to substantially lower costs compared to branded biologics, some of which still command high prices. While the difference in price between biosimilars and biologics may not be as great as the gap between generics and pharmaceuticals, the impact for payers and patients could be notable.