Topic 4: bioequivalence and biowaivers

Question 1

Generic vs innovator (getting to market)

Answer 1

• Generic is a copy of the innovator
• Companies seeking to market and sell a generic need only to show bio-equivalence through disintegration and dissolution testing
• Generic sponsor can apply for an abbreviated new drug application
• If bio-equivalence is verified generic sponsor can receive a biowaiver which means they can sell the drug without actually conducting clinical trials

Question 2

Biosimmilars

Answer 2

Biosimilars a generic reproductions of innovator biologics. As these cannot be “bioequivalent” due to immunogenicity considerations they are deemed biosimilars. Unlike bioequivalents, biosimilars need to be tested for safety albeit the process is less onerous than that of testing for a new product