Senators seek changes to FDA guidance to speed entry of insulin biosimilars
As Eli Lilly announced Monday that it would introduce an authorized generic version of its Humalog insulin at half the original price, four senators on both sides of the aisle are seeking tweaks to recent FDA guidance to speed up the marketing of new biosimilar insulin products.
The guidance is part of FDA’s work to begin, starting in March 2020, transitioning approved marketing applications for a subset of products, including insulin and human growth hormone — previously approved as drugs under section 505 of the FD&C Act — to be biologics.
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