FDA leaves biosim trial data off product labels in new guidance

The FDA is out with new guidance for labeling biosimilar drugs--and it may not make some drugmakers happy. Regulators dismissed pharma's request that the label describe the clinical data copycats used for approval purposes. Instead, the FDA will rely heavily on the reference products' labels, focusing on the info physicians will need to use the product. Guidance (PDF) | More from FierceBiotech

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