Clinical Development Times for Biosimilars in the United States

ChangWon C Lee; Aaron S Kesselheim; Ameet Sarpatwari

doi:10.1016/j.mayocp.2020.06.039

Clinical Development Times for Biosimilars in the United States

Mayo Clin Proc. 2020 Oct;95(10):2152-2154. doi: 10.1016/j.mayocp.2020.06.039.

Authors

ChangWon C Lee¹, Aaron S Kesselheim¹, Ameet Sarpatwari²

Affiliations

¹ 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.
² 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. Electronic address: asarpatwari@bwh.harvard.edu.

PMID: 33012346
DOI: 10.1016/j.mayocp.2020.06.039

Abstract

Biosimilars 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.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Biosimilar Pharmaceuticals*
Clinical Trials, Phase I as Topic / statistics & numerical data*
Drug Development / statistics & numerical data*
Humans
Time Factors
United States

Substances

Biosimilar Pharmaceuticals