FDA Releases Long Awaited Biosimilar Interchangeability Draft Guidance

• By: Staff Editor
• Date: January 18, 2017
• Source: http://www.fda.gov

FDA Releases Long Awaited Biosimilar Interchangeability Draft Guidance

The US FDA has finally issued its much awaited draft regulation on biological product interchangeability. The regulatory guidance has been expected since 2010, when Patient Protection and Affordable Care Act was signed into law, that amended the Public Health Service Act to create an abbreviated license pathway for biological products that are proved to be biosimilar or interchangeable with an FDA-licensed biological product.