Hamburg Says Biosimilar Guidances, Decisions Expected Very Soon

FDA Commissioner Margaret Hamburg said the agency will put out biosimilar guidances and decisions that may touch on important topics -- such as naming, labeling and interchangeability -- very soon, following “lots of meetings with prospective companies” and as the agency reviews five biosimilar applications that have been taken up by the agency. Hamburg spoke on the topic at a House Appropriations subcommittee hearing Wednesday (March 4), where Rep. Kevin Yoder (R-KS) asked when FDA will release guidance on interchangeability,...