In February, the US Food and Drug Administration (FDA) accepted Mylan’s abbreviated Biologics License Application (aBLA) for the Neulasta biosimilar for review, but the FDA is yet to approve the application.
In its complaint, Amgen explained that approval of the biosimilar and Mylan’s potential importation and sale of its product would be “infringing”.
Both Amgen and Mylan started exchanging information in March this year under the so-called ‘patent dance’ procedure of the Biologics Price Competition and Innovation Act (BPCIA).
However, Amgen suggested that Mylan failed to provide certain information and “materially prejudiced and impeded Amgen’s ability to review the Mylan aBLA”.
Amgen alleged that Mylan “failed to provide other information that describes the process or processes used to manufacture the biological product that is the subject of’ the Mylan aBLA”.
In June, Amgen took to the US Supreme Court to challenge a US Court of Appeals for the Federal Circuit decision that said the patent dance procedures were completely optional and that a biosimilar applicant can decide to withhold a copy of its biosimilar application.
Amgen said the patent dance was part of the BPCIA’s trade-off and balanced the rights of reference products against those of biosimilar applicants.
The case was sent back to the court of appeals to for a further ruling.