FDA Issues Draft Guidelines for Biosimilars


Last Thursday, the FDA issued the first set of long-awaited draft guidelines for the regulatory approval of follow-on biologic drug products, or "biosimilars," under the Biologics Price Competition and Innovation Act of 2009 ("BPCIA"). While the pharmaceutical industry has eagerly awaited the FDA's announcement of its views on the regulatory requirements for biosimilar approval, the agency has declined, for now, to provide the type of detailed description many have been seeking. Instead, the draft guidelines set forth general principles to be applied during the approval process and made clear that the regulatory requirements that biosimilar applicants will be required to meet will be highly product dependent. As a result, while these guidelines provide useful insights into the FDA's views on the approval of biosimilar applications, the full scope of the challenges associated with obtaining regulatory approval for biosimilars remains uncertain.

The FDA draft guidelines are composed of three "Guidance for Industry" documents:

• "Quality Consideration in Demonstrating Biosimilarity to a Reference Protein Product" ("Quality Guidelines")
• "Scientific Consideration in Demonstrating Biosimilarity to a Reference Product" ("Scientific Guidelines")
• "Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and
Innovation Act of 2009" ("Biosimilars Q&A").

Although not legally binding, these guidelines provide a description of the FDA's most current thinking about the biosimilar approval process. The Quality Guidelines set forth the analytical requirements for biosimilar approval, while Scientific Guidelines describe the clinical trial requirements for biosimilar approval. The Biosimilars Q&A provides general principles the FDA intends to apply to the approval of biosimilar products. Public comments on the draft guidelines will be accepted for 60 days.

Please see full alert below for more information.

LOADING PDF: If there are any problems, click here to download the file.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Patterson Belknap Webb & Tyler LLP | Attorney Advertising

Written by:


Patterson Belknap Webb & Tyler LLP on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:

Sign up to create your digest using LinkedIn*

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.

Already signed up? Log in here

*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.