On April 1, 2013 the Food and Drug Administration released its fourth draft guidance document outlining the regulatory pathway for biosimilars as it pertains to formal meetings with the FDA and review of applications. The Biosimilar User Fee Act of 2012, enacted as part of the Food and Drug Safety and Innovation Act (FDASIA), amended the Food, Drug and Cosmetic Act to authorize a new user fee program for biosimilar products.

The document entitled, “Formal Meeting between the FDA and Biosimilar Biological Product Sponsors or Applicants,” encapsulates five different kinds of meetings the FDA will engage in, and the timeline and fees related to each. “This guidance is intended to assist sponsors or applicants in generating and submitting a meeting request and the associated meeting package to the FDA for biosimilar biological products intended to be submitted under 351(k) of the Public Health Service Act,” stated FDA. The draft guidance also states the standardized procedures for requesting, preparing, scheduling, conducting and documenting the meetings with the FDA. This guidance is open for comment for 60 days after publication in the Federal Registry

See FDA guidance document here

FDA issued its first highly-anticipated guidance on the biosimilar approval pathway on February 9, 2012. The guidance outlines the requirements for industry when submitting a biosimilar application for approval under the new abbreviated regulatory pathway that was included in the Patient Protection and Affordable Care Act signed into law on March 23, 2010.

Guidance Documents

  1. Scientific Considerations in Demonstrating Biosimiliarity to a Reference Product (Docket Number FDA-2011-D-0605):
  2. Quality Considerations in Demonstrating Biosimiliarity to a Reference Protein Product (Docket Number FDA-2011-D-0602):
  3. Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 (Docket Number FDA-2011-D-0611):
  4. Formal Meetings between the FDA and Biosimilar Biological Product Sponsors or Applicants (Docket Number FDA-2013-D-0286):
  5. Draft Guidance for Industry on Clinical Pharmacology Data To Support a Demonstration of Biosimilarity to a Reference Product; Availability (Docket No. FDA–2014–D–0234)


ASBM’s Participation in FDA Public Meeting on Biosimilar Development

On May 11, 2012, the FDA held its first public hearing on the draft guidances relating to the development of biosimilar products in the U.S. The FDA considered the information it received from the public hearing as it moved forward to finalize the guidances. The majority of speakers were complementary of the scientific approach the FDA was utilizing to bring biosimilars to patients in the U.S. ASBM Chairman Richard Dolinar, M.D. and nine member organizations provided testimony during the daylong hearing.

In his testimony, Dr. Dolinar stressed the need for the FDA to make patient safety the cornerstone of the biosimilars pathway. In so doing, he called for (1) robust clinical testing; (2) the establishment of steps to monitor the global supply chain and manufacturing process; (3) the creation of track, trace and naming provisions; (4) the development of clear packaging, labeling and prescribing information; and (5) very close and deliberate scrutiny of a biosimilar before it is deemed interchangeable.

In addition to Dr. Dolinar’s testimony, several other Alliance member organizations echoed the need for keeping patient safety paramount as a pathway is created.

Alliance members who testified included: