Case Study

Biosimilar Monoclonal Antibodies approval across Japan, EU and US

Biosimilar Monoclonal Antibodies approval across Japan, EU and US

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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

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