Less Clinical Data May Mean Fewer Prescriptions for Biosimilars

by Amanda Conschafter, Blog Editor

The Food and Drug Administration may require less clinical data to approve biosimilars (imitations of powerful biological medications). But new data suggests that doctors are split over how the FDA’s approach will affect their prescribing practices. A First Word poll of oncologists and rheumatologists shows that the level of clinical data produced affects doctors’ predicted approach to prescribing biosimilars, while efficacy, safety and product history remain doctors’ primary concerns for biosimilar use overall.

FDA guidance published earlier this month suggested that data collected in non-clinical settings may affect the FDA’s decision about which patients are candidates for biosimilars. Such data would stem from analyses of, for example, the drug’s protein structure and functional properties, as opposed to information collected in a clinical environment.

But data of this variety doesn’t give all doctors full confidence for prescribing biosimilars. Thirty-four percent of physicians polled said they would not prescribe biosimilars with only limited clinical data, while 37 percent indicated they would proceed with only some usage (prescribing biosimilars to up to 50 percent of eligible patients). And 65 percent of poll respondents expressed concern about the potential for biosimilars to be deemed “interchangeable,” or capable of producing the same affects as biological medications, with only limited clinical data.

Biosimilar medications approved with purely non-clinical data elicited even higher levels of concern in physicians polled. Seventy-eight percent of rheumatologists said they would not prescribe a biosimilar medication approved under these conditions.

Beyond specific prescribing practices, an overwhelming majority of physicians polled want to see “full approval history of the product, including…clinical safety, efficacy, and immunogenicity data” included in the final product label and summary of characteristics. These preferences and other physician concerns, particularly where they reflect patient safety issues, may well impact the FDA’s forthcoming final guidance and initial approval of biosimilars.


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