The FDA released a draft guidance titled Considerations in Demonstrating Interchangeability With a Reference Product: Update (here), which acknowledges the FDA’s continued evaluation of the biosimilar data collected to date and worldwide acknowledgement that if a biosimilar is approved using the analytical methods required for approval, including appropriate in vitro testing, there should be no […]
Introduction On November 17, 2022, Sen. Mike Lee (R-UT) introduced a Bill entitled the “Biosimilar Red Tape Elimination Act” with the intent to increase competition within the US biosimilar market and reduce consumer costs associated their development. The Bill proposes to eliminate the interchangeability requirement of conducting switching studies associated with biosimilar drug development. In […]
Everyone knew this day would come and it has been a long time in coming. Yesterday, the FDA approved the first interchangeable biosimilar for an insulin product. An interchangeable biosimilar, like an AB-rated generic product, can be substituted at the pharmacy without intervention of the healthcare provider. According to the FDA announcement, “Semglee (insulin glargine-yfgn) […]
The FDA has just published a new draft Q&A Guidance document regarding BLA submissions for biosimilar products and interchangeable biosimilar products, as well as recommendations for labeling of interchangeable biosimilar products. This guidance (Biosimilarity and Interchangeability: Additional Draft Q & As on Biosimilar Development and the BPCI Act is available here) and supplements the two […]
