Generic / Large Molecule / Regulatory Guidance

Industry Groups Push FDA to Release Final Biosimilars Guidance

Jan 13, 2015

The Biotechnology Industry Organization (BIO) has called on the FDA to release final guidance on biosimilars, and specifically address processes and scientific criteria for biosimilar approval, outline an approach to naming and labeling, and clarify the conditions for determining a biosimilar to be interchangeable with its reference biological.

BIO is requesting published guidance documents with the opportunity for public comment, rather than the FDA's advisory committee meetings.

BIO, as the world's largest trade association representing biotechnology companies, is a clear supporter of the Biologics Price Competition and Innovation Act (BPCIA) and is committed to preventing any legislative erosion of the BPCIA.

See the FDA draft guidances on biosimilars here

Read the BIO press release