Biosimilar Development
Biosimilar development requires substantial time and investment. A typical biosimilar takes 7-8 years to develop, at a cost of between USD 75 and 250 million, with clinical trials that may involve about 500 patients.That compares to 8-10 years for a new drug application, at a cost of USD 800 million, including up to 1000 patients in clinical trials. For a small-molecule generic, by comparison, development may be completed in 2-3 years, at a cost of USD 2-3 million.
