11^th European Biosimilars Congress

This presentation addresses the challenges sponsors face in developing biosimilars for the global market amidst a myriad of varying regulatory requirements. Differences in approach between CHMP and FDA will be considered with respect to the impact of variances in the regulatory frameworks and conflicting quality and clinical data requirements. Consideration will then be given to the need for inclusion of local patients in order to gain regulatory marketing approval as is the case for example in China, Japan, Russia and India. Also in some regions there is the need compare the biosimilar against reference product sourced from specific regions at the quality and sometimes the clinical level. The timings for clinical trial approval and potential for interaction with regulatory authorities in order to seek feedback on the suitability of the proposed development program will also be discussed.