BioCentury
ARTICLE | Politics & Policy

FDA issues additional biosimilars draft guidance

May 13, 2015 2:36 AM UTC

FDA issued draft guidance on biosimilars related to requirements for demonstrating interchangeability of a biosimilar with a reference product, terms for establishing the exclusivity period for pioneer biologics and provisions related to BLA submission requirements. However, FDA did not settle important outstanding questions on interchangeability and exclusivity.

The guidance, which provides questions and answers about implementation of the biosimilars pathway, says FDA is "continuing to consider the type of information sufficient to enable FDA to determine that a biological product is interchangeable with the reference product." The document also says the agency is "continuing to review the reference product exclusivity provisions" of the Biologics Price Competition and Innovation Act of 2009 (BPCIA), which provides a 12-year exclusivity period protecting pioneer biologics from biosimilar competition. ...