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- ChangWon C Lee, Aaron S Kesselheim, and Ameet Sarpatwari.
- Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA.
- Mayo Clin. Proc. 2020 Oct 1; 95 (10): 2152-2154.
AbstractBiosimilars are versions of biologic drugs made by different manufacturers that can help lower spending by promoting competition. However, few biosimilars are currently available in the US. To assess the role of testing requirements in this outcome, we investigated clinical development times for 40 biosimilars that initiated phase I testing between 2012 and 2015. We found that most biosimilars underwent phase III testing with an average trial length of 22 months. Of 20 biosimilars that had been approved by October 2019, the median time from initiation of phase I testing to approval was 69.9 months. These findings reveal a high testing bar for approval that likely contributed to limited market entry.Copyright © 2020 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.
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