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FDA Defends Stance on Biosimilar Product Labeling

The agency is trying to avoid any "potential confusion."

The FDA recently posted a message, written by Dr. Christl, the Associate Director for Therapeutic Biologics in the Office of New Drugs at the agency's Center for Drug Evaluation and Research, explaining their stance on biosimilar labeling.

Titled "From our perspetive," the message explains that although there is "a lot of work to do," the agency thinks, "that our approach to biosimilar labeling will be truly beneficial to health care providers as they consider prescribing options and the risk-benefit decisions for their patients."

Christl explains that the agency has taken an "approach to avoid potential confusion or misinterpretation of the comparative data."

"While we recommend that biosimilar labeling include biosimilar product-specific data necessary to inform safe and effective use of the product, we generally do not recommend that comparative data supporting the demonstration of biosimilarity be included in biosimilar product labeling," she writes.

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