8 December 2016 - 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 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.

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