The ruling begins to set the record straight in what could be a prolonged battle over the requirements of the Affordable Care Act’s (ACA) biosimilars pathway. One particular point of contention between Sandoz and Amgen is whether or not Sandoz was required to disclose the way it intends to manufacture its biosimilar -- known as Zarxio (filgrastim-sndz), which received FDA approval in early March.
The US Court of Appeals for the Federal Circuit said in the ruling that the manufacturing disclosure is mandatory, noting “when an applicant chooses the abbreviated pathway for regulatory approval of its biosimilar product, it is required to disclose its aBLA [abbreviated Biologic License Application] and manufacturing information to the RPS [reference product sponsor] no later than 20 days after the FDA’s notification of acceptance.”
The ruling on Sandoz’s Zarxio (filgrastim-sndz) Tuesday follows another ruling by a California judge in March, which said Sandoz’s failure to provide this information to Amgen should not stop the biosimilar from coming to market.
But this latest ruling offered a more assertive opinion on what is required by the biosimilars law. “The BPCIA [Biologics Price Competition and Innovation Act] as enacted leaves no uncertainty as to which of its provisions are mandatory and which are permissive,” the court said.
The marketing of Zarxio will come as Neupogen brought in $839m in US sales last year for Amgen, though sales have been falling as patients switched to a newer version of the drug, called Neulasta, according to Bloomberg News.
“As the majority opinion recognizes, this case requires us to ‘unravel the riddle, solve the mystery, and comprehend the enigma’ that is the BPCIA,” the appeals court concluded, with a nod to Winston Churchill’s take on Russia in a BBC radio address.