FDA action 'provides potential for chemically synthesized follow-on insulins'

The US Food and Drug Administration’s (FDA) Janet Woodcock has delivered a statement on the impact of the agency’s proposals on bringing low-cost biosimilar and interchangeable protein products to market.

From March of next year, approved New Drug Applications (NDAs) for biologics will be deemed to be licenses for the biological products, or Biologics License Applications (BLAs).

Once an approved NDA for a biologic, such as an insulin treatment, is deemed to be a BLA, then the therapy can then be used as a reference by an applicant seeking approval of a proposed biosimilar or interchangeable product.