After Gaining FDA Approval, Biosimilars Face Hurdles of Clinician, Patient Acceptance

Humira’s biosimilar competitors have overcome the approval and patent fight process, only to run straight into what may be an even bigger challenge: getting the drugs past pharmacy benefits manager (PBM) gatekeepers and earning the trust of clinicians and patients.

While the FDA requires all biosimilars to be clinically identical to the reference product — made with the same type of living sources; administered the same way; and have the same strength, dosage, potential treatment benefits and side effects — history shows very clearly that prescribers and patients still get the jitters about switching.

This preference for the name brand was obvious in last year’s report by the Office of the Inspector General, which examined the uptake of existing biosimilars and estimated existing and potential Medicare savings. Using Medicare data, the report found that biosimilars’ reference products were still being prescribed about five times more frequently than the biosimilar itself.

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