BIO urges US FDA to release guidance on biosimilars

The US trade group the Biotechnology Industry Organization (BIO) has called on the Food and Drug Administration to release final guidance on processes and scientific criteria for the approval of biosimilars, outline its approach to naming and labeling, and clarify its conditions for determining a biosimilar to be interchangeable with its reference biological.

“This week’s advisory committee meetings facilitated important discussion of the scientific approach of reviewing biosimilar applications and we encourage this positive momentum, however, we believe the appropriate way to develop policy on such a significant new approval pathway is through published guidance documents with the opportunity for public comment, rather than through single-application advisory committee meetings,” said Jim Greenwood, BIO’s president and chief executive, hot on the heels of an FDA advisory panel recommending approval of a Neupogen (filgrastim) biosimilar from Sandoz (see separate story).

BIO and its member companies supported and worked for the enactment of the Biologics Price Competition and Innovation Act (BPCIA) because its provisions help to balance the desire to provide greater choice for patients and physicians through market entry of safe and effective biosimilars with the need to preserve incentives for the innovation of new biologics that not only save and improve lives but also provide the blueprint for future biosimilar products.