Amgen sued over ‘withholding’ biosimilar information

Amgen has been accused of withholding confidential information about its proposed biosimilar of Genentech’s cancer drug Avastin (bevacizumab).

Filed on Wednesday, February 15 at the US District Court for the District of Delaware, Genentech’s case claimed Amgen had violated the Biologics Price Competition and Innovation Act (BPCIA).

According to the complaint, Amgen has sought Food and Drug Administration approval to market a biosimilar of Avastin, Genentech’s “best-selling” cancer drug.

Amgen has purported to opt into the BPCIA’s information exchange procedures, according to Genentech.

Genentech claimed that it should have been given access to Amgen’s manufacturing information which is highly relevant for Genentech to determine whether the biosimilar would infringe its patents.

The information was also needed to ensure Genentech had sufficient time to potentially assert patentsbefore Amgen launches its product.

Genentech claimed that it faces an imminent deadline to provide Amgen with a list of potentially infringed patents because Amgen failed to supply all information needed by Genentech.

The suing company said: “The consequences are potentially disastrous—under the BPCIA, if Genentech fails to list a patent, it could be barred permanently from asserting that patent against Amgen’s biosimilar Avastin.”

In the complaint, Genentech has asked the court for a speedy hearing and a judgment that says Amgen failed to comply with the BPCIA.

It has also asked for Amgen to be enjoined from marketing the biosimilar until Genentech is in a position to gain information needed to potentially assert patent claims.