The New Wrinkle in the US Biosimilars Approval Process


GPhA takes issue with FDA timeline.

According to an amicus brief filed by the Generic Pharmaceutical Association's Biosimilar's Council (GPhA), a rumble may be brewing that could delay the approval process of biosimilars in the US by six months.

As part of Obamacare, the Biologics Price Competition and Innovation Act (BPCIA) states an expedited approval pathway can be used and appropriately marketed only when--and after--the reference biologic is in market for 12 years.

The US Food and Drug Administration (FDA) will only accept biosimilar filings (351(k)) five years after the original biologic is licensed by the FDA, and after the filing is accepted, biologics and biosimilars manufacturers are expected to exchange patent and manufacturing information to continue the “patent dance" and work out any conflicts. The problem is the provision in the BPCIA that directs biosimilar makers to provide a 180-day notice to biologics manufacturers prior to marketing the biosimilar, but only after a biosimilar is licensed by FDA.

The History

In August, Amgen announced Apotex had provided it with a copy of its biologics license application (BLA) for a biosimilar of the neutropenia treatment Neulasta (pegfilgrastin) and exchanged information on the biosimilar's manufacturing and Amgen patents that the biosimilar could infringe on.

Amgen sued Apotex because Apotex argued that by complying with the information exchanges it was allowed to opt out of providing the 180-day notice of marketing.

In early December a federal judge in Florida ruled against Apotex and found that the 180-day notice provision is actually mandatory, though Apotex appealed that decision.

The only other case to deal with such a scenario involves Sandoz's biosimilar of Amgen's Neupogen, which is the first US biosimilar approved under the BPCIA. That biosimilar’s launch, approved as Zarxio, was delayed for 180 days after FDA approval because of the notice provision, although those companies did not engage in the so-called patent dance as Apotex and Amgen did.


Six months in delay may equate to millions of dollars for development organizations -- and time for patients to be given another medicinal option.

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