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.
May 19, 2017
BPC thanks FDA for its thoughtful draft guidance “Considerations in Demonstrating Interchangeability with a Reference Product" and submitted a comment providing our perspective. When final, the guidance will provide important scientific information for manufacturers to consider when seeking licensure for proposed interchangeable products. Once available, it is critical that we, as prescribers, have all of the information we need to make informed decisions with our patients. Read More ›
May 19, 2017
On Friday, May 19, 2017, six groups representing a broad spectrum of biologic prescribers – AfPA, AACE, ACR, AGA, BPC and CSRO – submitted a comment to FDA commending the agency for its thoughtful draft guidance entitled “Considerations in Demonstrating Interchangeability with a Reference Product.” BPC believes that, once available, this guidance will ensure prescribers have more of the information necessary to make informed decisions with their patients. As FDA continues to develop the draft guidance, BPC urges the agency to promote transparency and patient safety by paying particular attention to the data, including robust clinical switching studies, required to demonstrate interchangeability. Read More ›
May 5, 2017
View BPC's educational video, "Biosimilars: The Path to Approval" to learn why biosimilars can never be precisely duplicated, how indication extrapolation works and more on the rigorous, but abbreviated path to approval. Doctors and patients can have a degree of confidence in the safety of biosimilars, yet will have much to learn as their use increases in the clinical practice. Read More ›
October 3, 2016
Morning Consult published an opinion editorial by Dr. Joshua Stolow of AfPA and CSRO discussing how the FDA has made great strides in developing guidelines for biosimilars, however, there still remain areas that must be addressed to ensure maximum patient safety and efficacy. Read More ›
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