Interchangeable biosimilars

29
Jul
First

Big Day in the Biosimilar World – First Interchangeable Product Approved for Insulin!

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) […]

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20
Nov

New Draft FDA Guidance on BLAs for Biosimilars and Interchangeable Biologics

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 […]

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