publication date: Apr. 1, 2016

Drugs and Targets

FDA Publishes Draft Guidance On Biosimilar Product Labeling 

 

FDA published a draft guidance of recommendations for biosimilar product labeling.

Based on a demonstration of biosimilarity, biosimilar product labeling should include a description of the clinical data that supported safety and efficacy of the reference product as described in the FDA-approved product labeling for the reference product, the agency said.

“FDA recommends that biosimilar product labeling incorporate relevant data and information from the reference product labeling, with appropriate product-specific modifications. The relevant data and information from the reference product labeling that should be incorporated into the biosimilar product labeling will depend on whether the applicant is seeking approval for all conditions of use (e.g., indication(s), dosing regimen(s)) or fewer than all conditions of use of the reference product for the biosimilar product,” the guidance said.

The guidance also included sections on approaches to content presentation and product identification, as well as recommendations on updating product labeling.

A PDF of the draft guidance can be found here.

FDA also published a blog post regarding their perspective on biosimilar product labeling.

“For the Full Prescribing Information, we recommend that biosimilar product labeling incorporates relevant data and information from the FDA-approved labeling for the reference product, along with any appropriate modifications specific to the biosimilar product. Note that a biosimilar product is not required to have the same labeling as its reference product, … Continue reading 42-13 FDA Publishes Draft Guidance On Biosimilar Product Labeling

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