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ASBM Submits Comments on FDA Draft Guidance Proposing Eliminating Switching Studies for Interchangable Biosimilars

On August 20th, ASBM submitted comments on the FDA draft guidance for industry entitled “Considerations for Demonstrating Interchangeability with a Reference Product: Update”, published June 20th. This draft guidance describes considerations regarding a switching study or studies intended to support a demonstration that a biological product is interchangeable with a reference product. 

From ASBM’s comments:

In addition to the FDA Draft Guidance, several legislative and regulatory proposals have been introduced at the state and federal level that would reduce requirements for interchangeability, declare all biosimilars interchangeable (making all biosimilars pharmacy-substitutable in the manner of generics), and/or restrict the FDA’s use of switching studies in determining interchangeability.  Data has shown, however, that these policies are strongly opposed by physicians who prescribe biologics. 

A 2024 survey of 270 U.S. physicians shows the importance of maintaining the robust data requirements undergirding the interchangeable designation. Respondents were drawn from nine practice areas: Dermatology, Endocrinology, Gastrointestinal, Immunology, Nephrology, Neurology, Oncology, Ophthalmology, and Rheumatology. All prescribe biologics.

  • 87% of respondents agreed that they are more comfortable switching a patient from an originator biologic to a biosimilar if that medicine has been specifically evaluated for the impact of switching on safety and efficacy.
  • 88% of respondents believe each interchangeable biosimilar should be individually evaluated specifically for the impact of switching on safety and efficacy.
  • Only 11% believe all biosimilars should be deemed interchangeable.
  • 85% of respondents agreed that only biosimilars that have been individually evaluated specifically for the impact of switching on safety and efficacy should be deemed interchangeable.

These new data are consistent with previous findings demonstrating the value of the FDA’s current data standards for interchangeable biosimilars in providing assurances to physicians that third-party substitution will not impact safety or efficacy. 

The role and value of switching studies in the approval of interchangeable biosimilars has been a subject of much discussion recently, and ASBM has generated several educational resources on the subject:

Read ASBM’s comments to the FDA here.

Read ASBM’s whitepaper about how misinformation regarding interchangeable biosimilars is undermining U.S. policy here. 

View the webinar on Interchangeable Biosimilars here.

Read the article in GaBI Journal here.