FDA calls for hearing on biosimilars legislation

The Food and Drug Administration will hold a two-day public hearing as it prepares to put into place regulations for the approval of generic versions of biological products, according to a draft document circulating among healthcare lobbyists.

The healthcare reform law allows for the approval of generic versions of biologics — also known as biosimilars — after 12 years of patent exclusivity. Biologics refers to medications and other medical products created through biological processes rather than chemistry.

The two-day hearing would take place on Nov. 2 and 3. Since it's a draft the document could change before publication in the Federal Register, but it provides insight into the issues on which the FDA is seeking comment from industry.

An FDA spokeswoman refused to comment on the draft.

"The purpose of this public hearing," the document states, "is to create a forum for interested stakeholders to provide input regarding the agency’s implementation of the statute concerning the following issues, among others: 

— Scientific and technical factors related to a determination of biosimilarity or interchangeability; 

— The type of information that may be used to support a determination of biosimilarity or interchangeability; 

— development of a framework for optimal pharmacovigilance for biosimilar and interchangeable biological products;

— scope of the revised definition of a  “biological product”; 

— priorities for guidance development;

— scientific and technical factors related to reference product exclusivity; 

— scientific and technical factors that may inform the agency’s interpretation of “product class” as it relates to available regulatory pathways for certain protein products during the 10-year transition period following enactment of the BPCI Act; and 

— the establishment of a user fee program for biosimilar and interchangeable biological products."