PhRMA and BIO Citizen Petition to FDA calls for biosimilar labeling guidance
Biosimilars will continue to become more widely available to patients in 2016 and beyond.
Biosimilars will continue to become more widely available to patients in 2016 and beyond.
Biosimilars will continue to become more widely available to patients in 2016 and beyond. PhRMA supports science-based regulation of biosimilars by the Food and Drug Administration (FDA). However, critical guidance on how they should be labeled to ensure regulatory transparency and accurate prescribing has yet to be issued by the Agency.
In a Citizen Petition to the FDA filed on December 22, 2015, PhRMA and the Biotechnology Innovation Organization (BIO) urged the Agency to include a number of key safety and transparency features – perhaps most critically a statement of biosimilarity within the FDA-approved labeling of a biosimilar that names the biosimilar’s reference product (the innovative drug on which the biosimilar is based) – as FDA develops regulatory guidance on this issue.
PhRMA’s and BIO’s requests outlined in the Citizen Petition include the following:
In a briefing for U.S. senators in September 2015, FDA promised to issue guidance on labeling of biosimilars, but has yet to do so. A response to the PhRMA/BIO Citizen Petition is required within 180 days.
For more information on biologics and biosimilars, go to: www.phrma.org/biosimilars.