Area of Focus / Biosimilars

What Are Biosimilars?

Congress created an abbreviated approval process for follow-on biologics in 2009, when it passed the Biologics Price Competition and Innovation Act (“BPCIA”).  Under the BPCIA, a follow-on biologic that is shown to be “biosimilar” to a previously-approved product (“reference product”) can be licensed without submission of the full complement of safety and effectiveness data typically required for licensure of a biological product.  42 U.S.C. § 262(k)(3).  To qualify as “biosimilar” to a reference product, a biological product must be “highly similar to the reference product,” and there must be “no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.”  42 U.S.C. § 262(i)(2). 

Where a biosimilar product is shown to meet certain additional requirements, the biosimilar is deemed to be “interchangeable” with the reference product.  An interchangeable product may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product.  42 U.S.C. § 262(i)(3).  To qualify a biosimilar product as interchangeable, it must be shown that the biosimilar product “can be expected to produce the same clinical result as the reference product in any given patient,” and that, for a biological product that is administered more than once to an individual, “the risk … of alternating or switching between use of the biological product and the reference product is not greater than the risk of using the reference product without such alternation or switch.”  42 U.S.C. § 262(k)(4).

What is Biosimilar Patent Litigation?

The BPCIA establishes a framework for resolving patent disputes between the applicant for licensure of a proposed biosimilar product and the sponsor of the corresponding reference product.  42 U.S.C. § 262(l).  Under this framework, the applicant provides the reference product sponsor with a copy of the application, and the parties exchange information and contentions regarding the patents that allegedly would be infringed by the proposed biosimilar product.  These exchanges are referred to as the “patent dance” and result in a list patents that will be subject to litigation between the applicant and reference product sponsor.  Much of the early litigation under the BPCIA has focused on the obligations of the applicant and reference product sponsor in the patent dance.

Useful Links

FDA Biosimilars Page

FDA Biosimilars Guidances

FDA Biologics Page

FDA Biologics Guidances

FDA Purple Book

42 U.S.C. 262 (the BPCIA)