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Considerations for biosimilar monoclonal antibody development: Lessons learned from clinical trials of trastuzumab
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Abstract:
A biosimilar product is defined as a biologic medical item that is highly similar to and clinically not different from the originator or reference product in terms of safety, purity, and potency. Given their structure complexity and manufacturing process variability, a biosimilar can only be defined as similar, but not identical. To support a demonstration of biosimilarity, a series of tests, including physicochemical analysis, pre-clinical studies and clinical trials, should be taken between the biosimilar and the originator, as well as approval by the authority before being marketed. The biosimlar of low molecular weight biologics was marketed in 2006, the new class of biosimilars, monoclonal antibodies (mAbs), was not approved by the European Medicines Agency (EMA) until 2013, next decade will be the fastigium of biosimilar development. In this paper, we will outline the EMA guidelines for monoclonal antibody biosimilar products and review the clinical trials of trastuzumab, an anti-HER2 monoclonal antibody indicated for breast cancer. A particular focus of discussion will be the clinical trial-related issues including trial design, selection and recruitment of sensitive study populations, extrapolation of indications, interchangeability with the reference product, post-authorization pharmacovigilance and final product labeling. Taking the EMA guidelines in account together with the lessons from previous clinical trials of trastuzumab, we strongly suggest that more precautions should be taken when biosimilar drugs are subject to evaluation and approval to ensure the efficacy and safety profiles are highly similar to those of their reference products for the safety of patients, particularly those with life-threatening diseases, such as cancer.
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Project Supported:
Project supported by the National Science and Technology Major Projects for “Major New Drug Innovation and Development” (No.2012ZX09304010, No.2014ZX09304311001)
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