Design and Implementation of Successful Regulatory Strategies in Biosimilar Development

Abstract

Biological medicines have had a profound impact on the health of patients suffering from many debilitating and life threatening diseases. They have been shown to provide “dramatically reduced disability for patients with inflammatory diseases, such as rheumatoid arthritis, extended the lives of patients with many cancers and also provide lifesaving replacement proteins for patients with rare diseases” (US Food and Drug Administration, http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm048341.htm; Krishnan et al., Ann Rheum Dis 71:213–218, 2012; Cox, Biologics 4:299–313, 2010). Biosimilars are copies of biological medicines and in order to obtain approval they are required to undergo head to head similarity exercises [CMC, nonclinical and clinical (as~needed)] against their reference product already marketed in the region/country of interest or countries with stringent regulatory requirements.