All publications of “Eduardo Pagani”1 results
Why are biosimilars much more complex than generics?
The regulatory demands for registering a generic medicine are physical-chemical tests and one comparative oral bioavailability clinical trial (bioequivalence).() This takes about 2 years, costs between USD$1 million and 2 million and enables claims for all indications accepted for the original drug. Demands for a biosimilar include many expensive and time-consuming comparative tests, and efficacy clinical trials for each indication. This takes from 5 to 9 years and costs over USD$100 million.() The concept of generic medicine was developed for […]