According to several recent presentations by U.S. Food and Drug Administration (FDA) officials, the agency has established three committees charged with discussing and coordinating issues related to biosimilars to ensure consistency in the regulatory approach and guidance to sponsors. While FDA set up this infrastructure some time ago, with the issuance of the Draft Guidances and the upcoming Stakeholder Meeting, it is important to understand where the key policy and precedent-setting decisions will be made.
Essentially, CDER and CBER have established a joint implementation committee, and CDER and CBER have each established their own review committees. CDER, however, appears to be playing a lead role in managing the process, as sponsors are directed under the Biosimilars Q&A Document to contact CDER’s Office of Medical Policy to initiate any questions or dialogue with the joint implementation committee.
We also note that there will be one or more representatives from the Office of the Commissioner – which may include the Office of the Chief Counsel – on the joint implementation committee. The Office of the Commissioner typically refrains from being directly involved in individual product development programs and reviews. However, the Office of the Commissioner is now well positioned to play a role on cross-cutting decisions impacting biosimilars, particularly as issues arise at the Center level. Whether the role of the Office of the Commissioner will be active or will be more that of an observer remains to be seen.
The FDA biosimilars committees are:
- The Biosimilar Implementation Committee;
- The CDER Biosimilar Review Committee; and
- The CBER Biosimilar Review Committee
The CDER/CBER joint Biosimilar Implementation Committee is the agency’s forum for discussing overarching policy issues, while the review committees focus on product-specific and scientific issues related to biosimilars development programs.
CDER/CBER Biosimilar Implementation Committee (BIC):
Janet Woodcock, M.D., and Karen Midthun, M.D, are the co-Chairs for the BIC (Dr. Woodcock is CDER’s Director, and Dr. Midthun is CBER’s Director). The lead for the committee is Rachel Sherman, M.D., who leads CDER’s Office of Medical Policy. This cross-center committee consists of staff from CDER, CBER, CDRH, and the Office of the Commissioner.
The BIC has been tasked with focusing on cross-center policy issues regarding implementation of the Biologics Price Competition and Innovation Act of 2009 (BPCIA), including developing initial interpretations of the statute, policy development, and agency resource needs.
CDER Biosimilar Review Committee & CBER Biosimilar Review Committee (BRC):
John Jenkins, M.D., Director of Office of New Drugs, is Chair of CDER’s BRC, and Robert Yetter, Ph.D, Associate Director for Review Management, is the Chair of CBER’s BRC, and both groups have members from both centers. These committees have been tasked with product-specific issues related to biosimilars within CDER.
Compiled with assistance from Anne R. Mutashi.