Tag: biosimilar vs generic

FDA Listing for Biosimilars: How They Are Evaluated and Approved

FDA Listing for Biosimilars: How They Are Evaluated and Approved

The FDA doesn't rate biosimilars like generics. Instead, it uses a strict, science-based process to ensure they're highly similar to reference biologics with no clinically meaningful differences. Learn how approval works, why they're not cheaper than expected, and what makes them different from generics.