What is a biowaiver?

Answer 1

A biowaiver is an exemption granted to a biopharmaceutical company, to show bioequivalence to a product.

Answer 2

A biowaiver is a regulatory provision that allows for the exemption of in vivo bioequivalence studies for certain drugs or formulations if sufficient in vitro data can demonstrate that the products are equivalent. This is typically based on the assumption that the drug's pharmacokinetics will not be significantly affected.