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Regulatory considerations in biosimilars: Asia pacific regions
Published in Preparative Biochemistry & Biotechnology, 2021
Anurag S. Rathore, Ankita Bhargava
Clinical Documentation: An applicant has to submit comparative clinical studies. In some cases, comparative PK/PD studies between the biosimilar product and the RBP may be sufficient to demonstrate clinical comparability if following conditions are met:The PK profile of the RBP is well characterized.There is sufficient knowledge of the PD properties of the RBP, including the binding to its target receptor(s) and intrinsic activity.The relationship between dose/exposure and response/efficacy of the RBP is sufficiently characterized.At least one PD marker is accepted as a surrogate marker for efficacy, and the relationship between dose/exposure to the product and this surrogate marker is well known.