US Solicitor General Calls on Supreme Court to Review Six-Month Delays to Biosimilar Launches

Posted 08 December 2016 By Zachary Brennan

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With the timing of all future US launches of biosimilars at stake, the US Solicitor General has called on the Supreme Court to review whether biosimilar companies should have to wait six months after US Food and Drug Administration (FDA) approval before launching their follow-on products.

“The proper interpretation of those provisions has a significant impact on the operation of the BPCIA [Biologics Price Competition and Innovation Act of 2009] and the ability of aBLA [abbreviated biologic license application] applicants promptly to bring their biosimilars to the public. And because the provisions are integrally related, the Court should consider all of the questions presented together. Both the certiorari petition and conditional cross-petition therefore should be granted,” Ian Heath Gershengorn, acting solicitor general of the US, and his deputies, wrote in an amicus brief to a lawsuit between biosimilar developer Sandoz and reference product manufacturer Amgen.

“The Acting Solicitor General’s recommendation that the Court grant cert is a very strong indicator that the Court will grant the petition and cross-petition,” Goodwin’s Big Molecule Watch reported late Wednesday.

Background

The BPCIA establishes an expedited process for licensing “biosimilar” versions of licensed biologics. In conjunction with that process, the BPCIA establishes a series of steps for the resolution of potential patent claims by the sponsor of the reference product and the biosimilar applicant, also known as the “patent dance.”

A section of that law says that a biosimilar applicant shall provide the sponsor of the reference biologic a copy of the biosimilar application and information about the product’s manufacturing processes. At issue is whether the applicant “shall provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the biological product licensed under subsection (k).”

Issues With Federal Circuit Ruling

In taking issue with the Federal Circuit’s ruling from last July, which effectively delays the launch of biosimilars by six months after FDA approval, the solicitor general says that under that court’s reading, “the owner of a biosimilar with an effective license could be forced to wait 180 days after FDA has authorized it to commence marketing, even if the sponsor had no arguably valid infringement claim to warrant such delay.”

Gershengorn also notes that the timing of biosimilars’ entry onto the market was a significant issue addressed by the BPCIA as it prohibits FDA from approving a biosimilar before 12 years after the reference product’s first licensure.

“Given the expressly granted exclusivity periods, it is particularly unlikely that Congress would have further delayed biosimilars’ marketing in such an indirect manner,” he writes.

And in calling on the Supreme Court to take up the dispute, the solicitor general notes that the questions presented in Sandoz’s petition and Amgen’s conditional cross-petition apply and will apply to other biosimilars up for FDA approval.

“The BPCIA represents a carefully calibrated legislative effort to promote innovation and competition in this important field, and the questions presented address core questions governing how the BPCIA operates,” the brief says. “This case is an appropriate vehicle through which the Court may resolve those questions.”

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Categories: Biologics and biotechnology, Government affairs, Manufacturing, Regulatory strategy, Regulatory intelligence, News, US, FDA

Tags: biosimilars, US Supreme Court, Federal Circuit, biosimilar launch

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