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This is where the worlds of clinical, regulatory, and economical outcomes for specialized pharmaceutical biotechnology meet: The Center for Biosimilars is your online resource for emerging technologies, with a focus on improving critical thinking in the field to impact patient outcomes.



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The aim of this review is to describe the inherent variability that is natural to biologics and, using the proposed etanercept biosimilar GP as an example, provide details on the "totality-of-the-evidence" concept, whereby all physicochemical, biologic, preclinical, and clinical data for a biosimilar and reference medicine are evaluated in an iterative, stepwise manner and shown to be highly similar. Analytical, functional, preclinical, and clinical data provide a comprehensive understanding of both GP and reference etanercept, and demonstrate a high level of similarity between the two products in accordance with regulatory requirements.



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