Abstract
The U.S. Food and Drug Administration (FDA) has implemented an abbreviated pathway to market for products that are demonstrated to be biosimilar to or interchangeable with a licensed biological reference product. We discuss comparative clinical studies supporting biosimilarity in the context of the stepwise approach suggested in FDA guidance documents. First we give a general overview of the Biosimilar pathway followed by a discussion of studies intended to support Biosimilar licensure and several examples with a primary focus being given to equivalence margin selection.
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Gwise, T.E. (2018). Comparative Clinical Studies for Biosimilars as Part of a Stepwise Approach. In: Gutka, H., Yang, H., Kakar, S. (eds) Biosimilars. AAPS Advances in the Pharmaceutical Sciences Series, vol 34. Springer, Cham. https://doi.org/10.1007/978-3-319-99680-6_18
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DOI: https://doi.org/10.1007/978-3-319-99680-6_18
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