Browsing: Biosimilars

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In this ‘Ask the Experts’ feature we will be discussing the use of biosimilars with a number of leading experts across the field. The series will explore the role of biosimilars, address the benefits and challenges of creating them and how they have gained momentum within the pharmaceutical industry.

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This entry is part 4 of 10 in the series Bioanalysis for Biosimilars Development

This chapter presents an overview of the requirements of comparative and biosimilarity testing between the innovator reference products and biosimilars with respect to product quality attributes, nonclinical and clinical studies, and current regulatory guidelines for biosimilar product development.

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