Industry Raises Concerns Over Proposed Biosimilarity Statement in Biosimilar Labeling Guidance

June 10, 2016

Despite the FDA extending the comment period for its recommendations on biosimilar labeling, several industry groups have still made public their concerns about the draft guidance.

GPhA and the Biosimilars Council said while they support most aspects of the guidance, they remain worried that the proposed biosimilarity statement is unnecessary.

Specifically, the groups say in their comments that the statement doesn’t provide any information for patients and providers that help them to use the product safely and effectively, adding that FDA labeling regulations do not identify any appropriate section of the labeling to place a biosimilarity statement.

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