October 18, 2016 BPC Supports FDA on BsUFA Proposal, Raises Guidance Timing Concerns

Robert M. Califf, M.D.
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993

RE: Comment on the Food and Drug Administration’s Biosimilar User Fee Act [Docket ID FDA-2015-N-3326-0012]

Dear Commissioner Califf:

On behalf of the Biologics Prescribers Collaborative (BPC), whose members regularly prescribe biologic medicines, we welcome the availability of biosimilars in the United States. The introduction of biosimilars will provide greater access to therapeutic options for patients who rely on biologic medicines.

BPC supports FDA’s continuing careful deliberation on biosimilar-related issues along with your expert and diligent review of medical products. In particular, the Collaborative is pleased that FDA has stated that it will make decisions on a case-by-case basis until it has the knowledge to impose a comprehensive regulatory framework for the approval and safe use of biosimilars. BPC realizes that this is a time and resource intensive process.

Therefore, we applaud FDA for the proposed recommendations being submitted for the BsUFA reauthorization for FY 2018-2022 and for taking the opportunity to set aggressive drug review timelines and goals, refine existing activities and remove provisions that are no longer needed.

Our organization commends FDA for acknowledging the concerns from physician and patient groups regarding the lack of guidances in place for the safe use of biosimilars. As such, our organization supports the request from FDA, which highlights the need for the agency to publish a final draft on several issues related to biosimilar development, including interchangeability, naming and labeling.

The Collaborative acknowledges that in order to accelerate patient access to safe and effective biosimilars, and to ensure “accuracy, consistency and timeliness” of the guidances, FDA needs additional resources. Therefore, we support FDA request of increasing staff capacity for the review and development of biosimilar-related regulations. We hope the BsUFA reauthorization and renewed attention to biosimilar development allows for expedited timing for guidances.

While it is important that timing is now outlined for guidances on Nonproprietary Naming of Biological Products and Labeling for Biosimilar Biological Products, receiving revised or final guidances by May 2019, and December 2017 for a draft guidance on interchangeability, we are concerned that this still permits a considerable period of time during which additional products will be approved and brought to market without final policy positions.

In closing, the Collaborative supports FDA’s proposed recommendations to the Biosimilar User Fee Act and look forward to approval of additional therapeutic options, particularly for those living with chronic illnesses often treated with biologics.


Biologics Prescribers Collaborative 

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