BIO Urges FDA to Release Guidance on Biosimilars

WASHINGTON, D.C. (January 7, 2015) – Today, the Biotechnology Industry Organization (BIO) calls on the FDA 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 CEO.

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. 

“For more than a decade, BIO has called for open, transparent, and science-based dialogue regarding biosimilars and we played a leading role in the effort to establish a pathway for the approval of biosimilars. There are fundamental scientific considerations at the heart of the debate regarding biosimilars, and we welcome and encourage a dialogue among all stakeholders as there are important implications for the appropriate use of all biologics, whether innovative or biosimilar,” said Greenwood.  

BIO is committed to preventing any legislative erosion of the BPCIA, and we will continue to advocate for appropriate implementation at FDA and CMS to ensure that these agencies’ regulatory and reimbursement decisions protect and benefit patients and encourage incentives for innovation.

BIO’s key principles for biosimilars include ensuring patient safety, recognizing scientific differences between drugs and biologics, maintaining the physician-patient relationship, and preserving incentives for innovation.

For more information on biosimilars and the biotechnology industry, please visit www.bio.org.