Methodologies in Biosimilar Product Development (2021)

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    Biologic drug products are therapeutic moieties that are manufactured using a living system or an organism, which are important life-saving drug products for patients with unmet medical needs. Biosimilars are similars that are made after the patent expiration of innovative biological products. To assist sponsors in developing biosimilar products, regulatory agencies such as the United States (US) Food and Drug Administration (FDA) have published several guidance since the BPCI Act was passed by the US Congress in 2009. Following the regulatory guidance, several methodologies for assessment of analytical similarity, pharmacokinetic and pharmacodynamic (PK/PD) similarity, and clinical similarity have been developed in the literature. However, due to the complexity of the structures of biosimilar products and the nature of the manufacturing process, the development of biosimilar products is very different from that of traditional small molecule (chemical) drug products. Thus, some practical and challenging issues such as the selection of similarity margin, drug interchangeability, non-medical switch, possible reference product change, extrapolation across different indications, etc. inevitably occur during the development of biosimilar products. Methodology development for addressing these practical and challenging issues is necessary for assuring an unbiased and reliable assessment of the treatment effect of the proposed biosimilar product under investigation.

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