High Court Offers Clarity on Biosimilar Law, Favors Faster Path to Market


The Supreme Court has issued its first interpretation of the biosimilar statute, which is likely to bring less expensive versions of biologic drugs to consumers faster.

In Sandoz v. Amgen, the U.S. Court of Appeals for the Federal Circuit had taken its shot at interpreting the Biologics Price Competition and Innovation Act (BPCIA), which provides an abbreviated approval pathway for biosimilars by allowing the applicant to rely on data used to approve the original biologic. In return for this reliance, the applicant has certain obligations to the owner of that biologic.

In a decision that many called “fractured,” the federal circuit ruled in favor of biosimilar applicants on the one hand by saying the BPCIA’s exchange of manufacturing and patent information between the applicant and patent owner—also called the “patent dance”—is optional. On the other hand, it also gave a victory to the patent owner by ruling that the 180-day notice that the applicant plans to bring the biosimilar to market can’t be given until the Food and Drug Administration approves the biosimilar. Biosimilar developers argued the second part of the ruling gave the patent owner six additional months of being able to sell its product without competition.

Both sides petitioned for review, and the supreme court on June 12 unanimously affirmed the federal circuit on the “patent dance” and reversed it on the 180-day notice, interpreting the BPCIA to mean an applicant can give the notice before or after the FDA approves of the biosimilar.

In the story I wrote, which you can read here, those I talked to described the ruling as siding with those who want biosimilars on the market sooner.

After the article was published, the Biotechnology Innovation Organization, which had filed an amicus brief supporting the position of the patent owner, issued a statement, saying the supreme court’s ruling “has effectively gutted a statute that had been carefully designed to facilitate timely resolution of patent disputes in order to avoid delaying market entry of biosimilar products. Importantly, it will do nothing to expedite the delivery of biosimilars to market. To the contrary, it is likely to delay patient access to biosimilars.”

We’ll have to see what the real impact of the ruling is. But has the court’s ruling provided the long-awaited certainty for those developing biosimilars and those who own the products of which the biosimilar is a highly similar version? It would appear so. For now.

In a concurrence, Justice Stephen Breyer echoed comments he made during the oral argument in which he said the FDA had the expertise to correctly interpret the BPCIA. Breyer wrote that if the FDA “after greater experience administering this statute, determines that a different interpretation would better serve the statute’s objectives, it may well have authority to depart from, or to modify, today’s interpretation.”

So, while there’s some certainty, there also appears to be an avenue available for any policy adjustments that might be needed.

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