As groups representing physicians who regularly prescribe biologics, we have a unique and important perspective about the use of these medicines. While biosimilars hold tremendous promise to increase access and affordability of these advanced medicines, their availability will increase the complexity of the treatment landscape. As such, the Biologics Prescribers Collaborative aims to ensure that sound policies are in place to promote the safest possible use of all biologics, including biosimilars, for all patients.
The Biologics Prescribers Collaborative’s mission is to ensure that physicians who prescribe complex biologic treatments are given a voice in discussions shaping policies that govern the use of biosimilars. Learn more about our four guiding principles and how we plan to achieve a unified prescriber voice.
August 24, 2016
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 PDUFA VI 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. Read More ›
August 2, 2016
As members of the Biologics Prescribers Collaborative (BPC) and professional organizations with biologics prescribers, we welcome the availability of biosimilars in the U.S. Biosimilars will provide greater access to more therapeutic options for the thousands of patient who rely on biologic medicines. We thank the U.S. Food and Drug Administration (FDA) for its thoughtful draft guidance “Labeling for Biosimilar Products” that makes important distinctions between the labeling needed for a biosimilar and a generic drug, especially for adding in a statement of biosimilarity. We believe the label of a biosimilar product should be transparent and facilitate access to data used in support of the biosimilar application. Read More ›
August 2, 2016
On Tuesday, August 2, 2016, eight groups representing a broad spectrum of biologic prescribers – AfPA, AACE, ACR, AGA, BPC, CSRO, Endocrine Society, and NASPGHN – commented on the U.S. Food and Drug Administration’s (FDA) draft guidance “Labeling for Biosimilar Products; Draft Guidance for Industry; Availability”, commending the agency on acknowledging the distinctions between the labeling needed for a biosimilar and a generic drug, especially for adding in a statement of biosimilarity. Read More ›
May 3, 2016
BiotechBlog published an opinion editorial by BPC co-convener Dr. Schimizzi of CSRO and Dr. Yapundich of AfPA discussing distinguishable biosimilar naming and other issues featured during the recent National Policy and Advocacy Summit on Biologics and Biosimilars convened by AfPA and BPC. Drs. Schimizzi and Yapundich explain their reasoning on why biologics, whether originator or biosimilar, require the kind of careful prescribing and robust monitoring that is possible only with distinguishable names. Read More ›
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