September 4, 2018 Biologics Prescribers Collaborative to Speak at FDA Hearing on Biosimilars

Physician Confidence is Cornerstone to Biosimilars Success

Dr. Dennis Cryer is speaking on behalf of the Biologics Prescribers Collaborative (BPC) at today’s U.S. Food and Drug Administration (FDA) public hearing on Facilitating Competition and Innovation in the Biological Products Marketplace.

“While there is much discussion on how to build a successful biosimilars market, a factor that cannot be overlooked is the need for physician confidence in this new class of medicines,” said Dr. Cryer. “These are highly complex medicines that will be used to treat patients living with complicated medical conditions. Physicians must be confident in the regulatory policies that support the safety and effectiveness of biosimilars, so we can put them to use to improve patient care and help contain costs.”

An important FDA guidance that has yet to be finalized addresses interchangeability. It will set the terms for whether pharmacists can substitute a biosimilar for an original biologic without the involvement of prescribers. As FDA works to finalize this draft guidance, regulators must strike the correct balance to ensure robust data collection and still encourage biosimilar manufacturers to seek interchangeable status.

To better understand prescriber sentiment when it comes to interchangeability standards, BPC conducted a survey on SERMO* of 300 U.S. physicians specializing in dermatology, gastroenterology, oncology and rheumatology. Results found nearly 70 percent are either “confident” or “extremely confident” that current draft FDA guidelines establish appropriate standards to demonstrate a biosimilar’s interchangeability. When asked about confidence level if FDA were to “relax” standards to demonstrate interchangeability, the percent of physicians who would feel “confident” or “extremely confident” falls to 46 percent.

“Any changes to regulatory standards should bolster physician confidence to promote the use of biosimilars,” continued Cryer. “BPC urges the FDA to maintain its current draft guidance for interchangeability and publish it as final. We strongly support the FDA as it continues its challenging work, bringing biosimilars to patients through science-based guidelines that build the confidence of physicians and the entire stakeholder community.”

The full hearing will be webcast and can be viewed here, starting at 9:00 a.m. ET.


About the Biologics Prescribers Collaborative (BPC)

The BPC is comprised of professional organizations which represent physicians who regularly prescribe biologics. BPC strives to ensure that sound policies are in place to promote the safest possible development and use of all biologics, including biosimilars, for all patients.

*SERMO is the leading global social network exclusively for doctors

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