Physician Groups Applaud FDA For Thoughtful Draft Guidance On Interchangeability, Urge For Robust Data To Demonstrate Biosimilarity
WASHINGTON, May 22, 2017 /PRNewswire-USNewswire/ -- Biologics Prescribers Collaborative (BPC) applauds the U.S. Food and Drug Administration (FDA) for its careful consideration of interchangeability in its draft guidance. As FDA continues to develop the draft guidance, BPC urges the agency to promote transparency and patient safety by paying particular attention to the data, including robust clinical switching studies,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.
On Friday, six groups representing a broad spectrum of physicians who prescribe biologics – Alliance for Patient Access, American Association of Clinical Endocrinologists, American College of Rheumatology, American Gastroenterological Association, Biologics Prescribers Collaborative and the Coalition of State Rheumatology Organizations – submitted a comment to the U.S. Food and Drug Administration (FDA) commending the agency for its thoughtful draft guidance entitled "Considerations in Demonstrating Interchangeability with a Reference Product." When final, the guidance will provide important scientific information for manufacturers to consider when seeking licensure for proposed interchangeable products. BPC believes that, once available, this guidance will ensure prescribers have more of the information necessary to make informed decisions with their patients.
These different specialty physician organizations joined together to discuss this draft guidance and outlined essential considerations prepared in comment from for FDA to consider when finalizing interchangeability guidance.
"BPC believes data required to demonstrate biosimilarity should be robust and risk-based to build prescriber confidence in this new class of medicine," stated BPC co-convener Dr. Dennis Cryer. He continued, our Collaborative of biologics prescribers believe "such confidence is particularly important for interchangeable biosimilars as these products may be substituted for the reference product without intervention from the prescribing healthcare provider."
In determining its final guidance on interchangeability, BPC's comment urges FDA to consider the following to promote transparency and patient safety:
Data required to demonstrate interchangeability should be more extensive than that required for determining biosimilarity. Clinical switching studies should be robustly designed and include a minimum of three switches between the reference product and proposed interchangeable product.
FDA should be cautious in granting indication extrapolation.
The label should include a statement of whether the biosimilar is interchangeable with the reference product and/or other biosimilars on the market and for which specific indications interchangeability was demonstrated.
Sponsors seeking to develop presentations for proposed interchangeable products that differ from the presentation of the reference product should provide scientific data demonstrating interchangeability for all presentations for which they seek licensure.
We appreciate the FDA's careful consideration in developing the draft guidance and information that should be considered to demonstrate interchangeability. Biosimilars hold tremendous promise to increase access to life-saving and life-enhancing biologic medicines for the millions of patients who rely on them.
As FDA evaluates additional biosimilars, and as further official agency guidances are issued, the BPC will continue to weigh in and to provide the critical perspective of biologics prescribers to help ensure patient safety.
The Biologics Prescribers Collaborative is an organization of groups representing physicians who regularly prescribe biologics that aims to ensure that sound policies are in place to promote the safest possible use of all biologics, including biosimilars, for all patients.
On Friday, six groups representing a broad spectrum of physicians who prescribe biologics – Alliance for Patient Access, American Association of Clinical Endocrinologists, American College of Rheumatology, American Gastroenterological Association, Biologics Prescribers Collaborative and the Coalition of State Rheumatology Organizations – submitted a comment to the U.S. Food and Drug Administration (FDA) commending the agency for its thoughtful draft guidance entitled "Considerations in Demonstrating Interchangeability with a Reference Product." When final, the guidance will provide important scientific information for manufacturers to consider when seeking licensure for proposed interchangeable products. BPC believes that, once available, this guidance will ensure prescribers have more of the information necessary to make informed decisions with their patients.
These different specialty physician organizations joined together to discuss this draft guidance and outlined essential considerations prepared in comment from for FDA to consider when finalizing interchangeability guidance.
"BPC believes data required to demonstrate biosimilarity should be robust and risk-based to build prescriber confidence in this new class of medicine," stated BPC co-convener Dr. Dennis Cryer. He continued, our Collaborative of biologics prescribers believe "such confidence is particularly important for interchangeable biosimilars as these products may be substituted for the reference product without intervention from the prescribing healthcare provider."
In determining its final guidance on interchangeability, BPC's comment urges FDA to consider the following to promote transparency and patient safety:
Data required to demonstrate interchangeability should be more extensive than that required for determining biosimilarity. Clinical switching studies should be robustly designed and include a minimum of three switches between the reference product and proposed interchangeable product.
FDA should be cautious in granting indication extrapolation.
The label should include a statement of whether the biosimilar is interchangeable with the reference product and/or other biosimilars on the market and for which specific indications interchangeability was demonstrated.
Sponsors seeking to develop presentations for proposed interchangeable products that differ from the presentation of the reference product should provide scientific data demonstrating interchangeability for all presentations for which they seek licensure.
We appreciate the FDA's careful consideration in developing the draft guidance and information that should be considered to demonstrate interchangeability. Biosimilars hold tremendous promise to increase access to life-saving and life-enhancing biologic medicines for the millions of patients who rely on them.
As FDA evaluates additional biosimilars, and as further official agency guidances are issued, the BPC will continue to weigh in and to provide the critical perspective of biologics prescribers to help ensure patient safety.
The Biologics Prescribers Collaborative is an organization of groups representing physicians who regularly prescribe biologics that aims to ensure that sound policies are in place to promote the safest possible use of all biologics, including biosimilars, for all patients.