New FDA Biosimilar Guidances and Proposed Rule

Today, the FDA issued four new biosimilar guidances, as well as a proposed rule.  According to a statement by FDA Commissioner Scott Gottlieb, two of the guidance documents—the draft guidance titled “The ‘Deemed to be a License’ Provision of the BPCI Act Questions and Answers” and the final guidance “Interpretation of the ‘Deemed to be a License’ Provision of the Biologics Price Competition and Innovation Act of 2009,” describe how, starting on March 23, 2020, FDA will “transition certain biological products currently approved as drugs under the Food, Drug, and Cosmetic Act [“FDCA”] to be licensed as biologics under the Public Health Service Act.”  The guidances discuss how certain biological products–such as insulin–will be removed from the Orange Book and transitioned to the Purple Book, and pending NDA supplements will be converted to pending BLA supplements.  According to Dr. Gottlieb, “[t]his transition of biological products currently regulated as drugs to being regulated as biologics will enable, for the first time, products that are biosimilar to, or interchangeable with, these products to come to market.”

The draft guidance titled “New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2)” and its companion, final guidance “Questions and Answers on Biosimilar Development and the BPCI Act” address questions relating to, among other things: demonstrating product interchangeability; pediatric requirements for interchangeability; post-approval manufacturing changes to licensed biosimilars; approval of uses, doses, and routes of administration that differ from the reference product; and interpretation of “protein.”

The proposed rule seeks to define the statutory terms “protein” as “any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size,” and “chemically synthesized polypeptide” as “any alpha amino acid polymer that is made entirely by chemical synthesis and is greater than 40 amino acids but less than 100 amino acids in size.”

The proposed rule also seeks to amend the definition of “biological product” in 21 CFR § 600.3(h) to reflect and incorporate changes made by the BPCIA, by:

  1. replacing the phrase “means any” with the phrase “means a,” to conform with the text of § 351(i)(1) of the Public Health Service Act;
  2. including “protein (except any chemically synthesized polypeptide)”; and
  3. adding paragraphs (h)(6) and (7) to § 600.3(h) to include the above definitions of the terms “protein” and “chemically synthesized polypeptide.”


Comments and suggestions regarding the draft guidances are due within 60 days of publication in the Federal Register; comments regarding the proposed rule are due within 75 days of publication in the Federal Register.