Petition Asks FDA to Tie Biosimilar Labeling to the Reference Product

Biosimilar labeling should piggyback on reference product labeling to bolster consumer confidence in this new class of medications, according to an FDA petition.

A citizen petition filed by a group of 15 investors asks the agency to “require all biosimilars to have the same labeling as their reference drugs” and to hold a public hearing on biosimilars to give stakeholders a voice in shaping future agency policy concerning biosimilars. The five-page petition was penned by the United Auto Workers Union’s Retiree Medical Benefits Trust and signed by a diverse group of investors, ranging from hospitals and consultancies to convents.

“In our view, biosimilars and interchangeable biologics represent an attractive investment opportunity as well as a safe alternative to specialty drugs whose cost threatens the financial sustainability of the markets in which our companies operate,” the petition states. “This approach is critically important in boosting investor confidence, signaling market certainty, and upholding the role of the FDA in determining biosimilarity and interchangeability.”

The group asks the agency to apply the same standard to all biologics that it did to the first biosimilar it approved — Sandoz’s chemotherapy biosimilar Zarxio — by tying the biosimilar labeling to that of the reference product.

“We believe that a differentiated labeling approach for biologics and biosimilars will send an inaccurate message to prescribers that biosimilars and interchangeable biologics are more dissimilar than highly similar to each of their reference products, raising the specter of safety issues,” the petition states.

The petition was prompted by requests that the labeling for biosimilars include information about the clinical trials conducted by the biosimilar sponsor and the licensure pathway under which the drug was approved, a view that the group rejects.

Read the petition here: www.fdanews.com/12-11-15-CitizenPetition.pdf. — Cameron Ayers

 

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