Biosimilars Forum Submits Comments in Response to FDA Draft Industry Guidance on Labeling for Biosimilar Products
Washington, DC, June 3, 2016 – The Biosimilars Forum – the nonprofit organization solely dedicated to expanding patient access to biosimilars in the United States today submitted comments in response to the Food and Drug Administration’s (FDA) draft industry guidance on Labeling for Biosimilar Products.
“The Biosimilars Forum appreciates the FDA’s position as stated in the draft guidance announcement that the biosimilar label should specifically address the purpose articulated in the Code of Federal Regulations (“CFR”) for labeling, and confirmation that the key safety and efficacy data are sourced from studies conducted by the originator. We believe the FDA’s stance that a biosimilar’s label may incorporate the reference product label content without requiring a verbatim reiteration of the label text is both practical and useful.
The Forum further applauds the FDA for taking the position that it is not necessary to identify in the label which indications were studied directly and which indications were extrapolated. We concur that there is a need for the FDA to determine on a case-by-case basis whether there is any clinically meaningful difference for approved indications, and as such the approval method for each indication is considered in that analysis.”
The Forum’s full comments can be viewed here.
About the Biosimilars Forum
The Biosimilars Forum is a nonprofit organization whose mission is to advance biosimilars in the United States with the intent of expanding access and availability of biological medicines, and improving health care. The founding members of the Biosimilars Forum represent the majority of companies with the most significant U.S. biosimilars development portfolios.
Contact:
Aimee Steel
202.828.1895
aimee.steel@hklaw.com
Media:
Lynn Blenkhorn
508.851.0930
biosimilars@fkhealth.com