Late last week, the U.S. Food and Drug Agency (FDA) dismissed a citizen petition filed by Amgen, Inc. asking the agency to require that biosimilar applicants provide the reference product sponsor with a copy of their application and information on their manufacturing processes.

At issue is the meaning of the term "shall" and whether the information-sharing and advance-notice provisions of the Biologics Price Competition and Innovation Act (BPCIA) that a biosimilar applicant "shall provide…a copy of the application submitted [to FDA]…and such other information that describes process or processes used to manufacture the biological product" is a mandatory requirement or an optional action for the biosimilar applicant. Arguing that "shall" implies the actions are mandatory, Amgen urged the FDA to take action requiring the applicant to comply with the provisions. The FDA's refusal to do so leaves a variety of disclosure options available for biosimilar applicants.

In the absence of a mandatory disclosure process, there is a real trade-off for biosimilar applicants to consider. Being receptive to disclosure affords an applicant many benefits of the safe harbor and information exchange, but may mean delays in product launch. A biosimilar applicant that prioritizes expedience over risk mitigation may believe "optional" disclosures are a waste of time. Further, if a biosimilar applicant is confident in its patent non-infringement and invalidity positions, being conservative and complying with the BPCIA's disclosure provisions may only to serve to delay the product launch and inevitable patent infringement suit.

Case History

Amgen and Sandoz are engaged in a legal battle centered on Sandoz's recently approved application for Zarxio, a version of Amgen's Neupogen and the first biosimilar cleared under the BPCIA. The dispute concerns the information-sharing provisions of the BPCIA, in particular, whether Sandoz must fully disclose proprietary information to Amgen regarding its Zarxio application and manufacturing processes.

The FDA's Reasoning

The FDA arrived at the following conclusions in their determination:

• The provisions of the BPCIA did not require them to impose a certification requirement as part of the biosimilar review process;
• The procedures for information exchanges and the resolution of certain patent rights between the biosimilar applicant and the reference product sponsor are parallel to, but separate from, FDA's review process; and
• Congress would have worded the BPCIA more like the explicit requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act), concerning certification for 505(b)(2) applications and ANDAs (i.e., the Hatch-Waxman provisions) had Congress intended certification to be required for biosimilar applications.

Significance

This is now the second high-profile decision on the side of biosimilars, as the FDA's interpretation of the disputed provisions of the BPCIA is consistent with the decision of the Northern District Court of California, currently under appeal to the Federal Circuit. Although not binding on the appeal process in the on-going litigation between Amgen and Sandoz, the FDA's interpretation of the disputed provisions of the BPCIA is consistent with the trial court's earlier decision and may have persuasive weight.