Friday, 20 Apr 2018

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Supreme Court Decision Favors Earlier Biosimilar Adoption

On Monday June 11th, the US Supreme Court unanimously ruled that biosimilar manufacturers can bring their drugs to market faster by eliminating the provision that the biosimar manufacturer had to give the innovator company 180 days notice before launching the new biosimilar.

The court was asked to decide on biosimilar patent dispute resolution procedures of the Biologics Price Competition and Innovation Act (BPCIA) or what has been called the "patent dance".  In the first part of the patent dance, the Court ruled against the requirement that a biosimilar applicant share its biosimilar application with the reference product sponsor.

The second ruling regarding a premarketing notice requirement, the Court held that the biosimilar applicant does not have to wait for FDA approval before giving 180-day premarketing notice, as long as there are no existing injunctions stemming from pending patent litigation.

The judgement stems from a dispute in Sandoz v. Amgen over Zarxio (the first biosimilar approved) competing with Amgen's Neulasta (pegfilgastrim or G-CSF).  A lower court had previously ruled against Sandoz challenge to the 180 day wait.  The Supreme Court ruled 9-0 in favor of Sandoz's assertion that a biosimilar manufacturers should not have to wait an extra six months after FDA approval to launch the new biosimilar product.

Sandoz's drug costs about 15 percent less than the brand name and Amgen has had 12 years of market exclusivity with the product. Sandoz argued that the 180 day could cost them millions in sales.

The 6 month wait orginated in a provision of the Affordable Care Act that requires a biosimilar manufacturer to give the brand-name manufacturer 180 days notice before launching.

While this a setback for Amgen, the FDA just rejected Coherus' biosimilar Neulasta (pegfilgastrim) where the FDA's complete response letter cited the need for more information regarding immunogenicity and manufacturing. 


The author has no conflicts of interest to disclose related to this subject

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