Patient groups bothered over diminished safety standards for biosimilars

June 10, 2015

Patients for Biologics Safety & Access (PBSA) sent a letter to FDA addressing safety concerns about final FDA guidance documents issued for biosimilars.

Patients for Biologics Safety & Access (PBSA) sent a letter to FDA addressing safety concerns about final FDA guidance documents issued for biosimilars.

PBSA is a coalition of more than 20 patient advocacy organizations dedicated to protecting patient access to safe and effective biologics

Final guidance language should clearly call for biosimilars to be labeled as a biosimilar and to indicate that a biosimilar is interchangeable with the reference product, according to the coalition.

LaMotte“Final guidance should strengthen patient safety protections and identify appropriateness of indication extrapolation,” said Larry LaMotte, spokesperson for PBSA. “Doing so will provide more transparency, clarity and safety protections for patients.”

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"Pharmacists and prescribers should work together to provide efficient medication therapy to patients,” LaMotte said. “Prescribers and patients should have all the information necessary to make a fully informed choice about whether to use an innovative biologic or biosimilar. The choice of products should not be determined by a pharmacist, regulator, or insurer but by a prescriber in consultation with his or her patient.”

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Final guidance language should clearly call for biosimilars to be labeled as a biosimilar and indicate whether or not the biosimilar is interchangeable with the reference product; final guidance should strengthen patient safety protections and identify appropriateness of indication extrapolation.

For more information, visit www.BiosimSafety.org or @BiosimSafety 

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