A clear split between the biosimilars industry and the branded biologics sector has emerged in comments submitted to the US Food and Drug Administration over draft guidance around biosimilar labeling and interchangeability.
Generics Bulletin Explains: Removing Interchangeability Information From US Biosimilar Labels
Biosimilars Industry Backs Latest FDA Labeling Guidance – But Originators Disagree
A clear divide between the biosimilars sector and the brand industry has been demonstrated by responses to a consultation over FDA draft guidance recommending that biosimilar labels remove information on interchangeability. Generics Bulletin explains the opposing positions.
