Unresolved Policy Issues Impact Patient Access to Biosimilars

By David Charles, MD and Mary Ann Chapman, PhD

More than five years have passed since Congress approved an abbreviated regulatory pathway for biosimilars under the Biologic Price Competition and Innovation Act as part of the Patient Protection and Affordable Care Act. Biosimilars are biological medications deemed highly similar, but not identical to, those already licensed by the US Food and Drug Administration (FDA). Congress’ vision – patient access to biosimilars – will come to fruition only if physicians have confidence in prescribing these medications. To instill that confidence, regulators must put into place standards that prioritize transparency and safety. Following the first biosimilar approval in March of 2015, healthcare providers, patient advocates, and policymakers should now consider the current status of biosimilars and some of the major issues impacting patient access to these medications: naming, prescribing information, indication extrapolation, and substitution.

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