FDA Denies Amgen’s Bid for Biosimilar Information Sharing

Biosimilars makers are not required to share their applications and manufacturing processes with the biologics company whose product they are copying, the FDA says, rejecting Amgen’s argument that the law that created the biosimilars pathway mandates disclosure of that information.

Amgen charged that Sandoz skirted the law by refusing to share information about its biosimilar of Amgen’s blockbuster chemotherapy product Neupogen.

The 2010 Biologics Price Competition and Innovation Act includes procedures for exchanging patent information and resolving disputes between the biosimilar applicant and the reference holder before the FDA issues a license. Amgen had asked the agency to declare that this disclosure was mandatory, but the agency disagrees.

In rejecting Amgen’s petition, the FDA says the procedures for information exchanges are “parallel to, but separate from” the review process.

The law does not give the FDA any role in monitoring or certifying the information exchange, the agency says in its March 25 letter to Amgen. The agency notes that the lack of an explicit certification requirement is in contrast to provisions governing brand and generic drugs, which require the agency to issue a certification that manufacturing information has been exchanged and patent issues resolved.

The FDA also says that Amgen’s language in its request — that the FDA “should” force certification for biosimilar applications — implicitly acknowledges that such a requirement is a matter of regulatory discretion and not compelled by law.

The agency notes that the issue should be resolved by the federal courts when they resolve Amgen v. Sandoz, in which Amgen is also arguing that the BPCI Act mandates the information exchange prior to biosimilar launch, the letter says.

The rejection follows a federal court ruling earlier last month denying Amgen’s bid for an injunction blocking Sandoz’s Neupogen  (filgrastim) biosimilar Zarxio (filgrastim-sndz). The Sandoz alternative received FDA approval earlier this month.

Amgen is appealing the decision. Read the FDA’s decision here: www.fdanews.com/03-15-FDA-Amgen.pdf. — Jonathon Shacat