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Providing analytical data on the comparison between a biosimilar and the reference product is a primary consideration in the development of biosimilars.
The long-term safety and efficacy of biosimilars are largely based on clinical studies that have already been conducted on the reference biologic, but these studies may not always be sufficient to ensure that the biosimilar can comparably replace the reference product. Having an analytical strategy can provide important clinical data to indicate similarity between a biosimilar and its reference product. BioPharm Internationalspoke with Patricia Hurley, PhD, senior director, Regulatory Consulting, and Duu-Gong Wu, PhD, senior director, CMC/Regulatory Consulting, both at PPD Consulting and Edward Tabler, associate director, PPD Laboratories’ bioanalytical lab, to gain insight into the impact that analytical testing on biosimilars has on their pathway to regulatory approval.
eBook: Biopharma Laboratory Best Practices 2018
When referring to this article, please cite it as F. Mirasol, "An Analytical Approach to Biosimilar Drug Development," BioPharm International Biopharma Laboratory Best Practices eBook (October 2018).