Case Study
Biosimilar Monoclonal Antibodies approval across Japan, EU and US
www.ndareg.com/casestudies | October 2013 Get in touch | Paula Warmer, Head of Communications and Marketing | Paula.warmer@ndareg.com Page.1 Biosimilar Monoclonal Antibodies approval across Japan, EU and US The Challenge NDA has been working with the client to develop a single global approach to gaining approval for their biosimilar monoclonal antibodies in EU, US and Japan. Strategies have been developed by the client and NDA that ensure