Michael J. Wise Partner

On December 14, the Federal Circuit issued a decision that further clarifies the ground rules for disclosures of product information by manufacturers of biosimilar pharmaceutical products. In particular, the Federal Circuit ruled in Amgen Inc. v. Sandoz Inc. that the original sponsors of biologics products cannot invoke state laws to compel applicants that are seeking to market biosimilar products to disclose information about those products under the Biologics Price Competition and Innovation Act (BPCIA).

The Food and Drug Administration recently revised its regulations governing submission and approval of new drug applications and abbreviated new drug applications. In the patent space, the America Invents Act provides a streamlined administrative process for challenging the validity of pharmaceutical (and other) patents. Congress also created an abbreviated pathway for biosimilar products, including a regulatory scheme for handling related patent disputes.

With biosimilars, the competitive forces shaping the global biologic brand markets reflect the traditional effects of the launch of a low-cost product. To assess the competitive landscape, marketers can evaluate four key domains of biologic differentiation: Construct, Delivery, Price, and Use.