The Biosimilar Drug Approval Pathway: Draft FDA Guidance and Beyond (Live Webinar)

The abbreviated approval pathway for biosimilars created by the Biologics Price Competition and Innovation Act (BPCIA) has been in effect since its enactment on March 23, 2010, but the first “351(k) application” has yet to be filed with the FDA. A salient cause of this lack of any “biosimilars” application filings is the absence (until now) of any guidelines from the FDA on procedures to be followed. On February 9, 2012, the FDA published three draft guidance documents on the development of biosimilar products. These guidances set forth general and undefined standards that it will use in determining what and how much evidence is enough for approval. Working with minimal guidance from the statutory language of the BPCIA, the agency has crafted a similarly non-specific and general scientific and quality considerations in evaluating “biosimilarity.” This presentation will provide a detailed analysis of the three biosimilar guidance documents, including:

  • What the guidance materials say and what they don’t
  • Early impressions and reactions to the biosimilar guidance documents
  • Lessons from the guidance and practical applications
  • Effect of the guidance on the 351(k) abbreviated pathway
  • Biosimilar proposal status update
  • Impact of the BPCIA and biosimilar guidance on other aspects of patent law


We will also discuss the possibility that the combination of these non-specific guidances and the complex litigation provisions of the law may provide incentives for biologic drug innovators to rely more heavily on the market exclusivity provisions of the Act than on patents, and we will discuss the implications of this eventuality.

While there is no fee to participate, all attendees must register in advance and, in order to receive MCLE credit, must participate individually.  Access an archived audio version of this webinar here. [NOTE: MCLE credit is not available for this archived recording.]

All registrants will receive an email confirmation and details for online participation.

MCLE credit is pending for the states of California, Georgia, Illinois, North Carolina, New Jersey, New York and Virginia.

MBHB is committed to educating clients and friends of the firm with respect to significant developments and trends in the areas of intellectual property law.