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FDA says biosimilar labels should rely on reference drug data
Modern Healthcare

Biologic manufacturers may not be pleased with the long-awaited biosimilar labeling guidelines released Thursday by the Food and Drug Administration.

The agency is recommending that labeling for biosimilars use the clinical data gathered by the product the biosimilar is intended to emulate. Regulators would also allow biosimilar labels to state that the product is biosimilar to the reference product but has product-specific modifications.

Biosimilars are derived from living organisms and therefore may not be identical to brand-name drugs.

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