Lee Rosebush Comments on New Biosimilar Labeling Draft Guidance

News / April 12, 2016

Partner Lee Rosebush is quoted in an article published by FDA News on Monday, April 4, 2016. In the article, “FDA Releases Biosimilar Labeling Draft Guidance,” Rosebush is quoted as saying that recent draft guidance released by the FDA regarding biosimilars labeling guidance gave industry what it wanted “to an extent.” He said the guidance it is very similar to generic drug labeling guidelines, except that the FDA allows the product to go for a very specific indication of the reference product.

Read the article (registration required).