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# Improve Biosimilar Development and Approval Efficiency
- URL: https://www.fdaweb.com/improve-biosimilar-development-and-approval-efficiency/
- Published: 2023-01-31T12:00:00.000Z
- Updated: 2026-09-14T18:13:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153662

Two FDAers from the CDER Office of Translational Sciences say there is an opportunity to leverage innovations in clinical pharmacology and related disciplines to improve the efficiency of biosimilar development and approval. Writing in an editorial introducing a themed issue of *Clinical Pharmacology & Therapeutics*, the authors [say](https://ascpt.onlinelibrary.wiley.com/doi/full/10.1002/cpt.2782?ref=fdaweb.com) one way is to leverage the use of pharmacodynamic biomarkers in clinical pharmacology studies in place of comparative clinical studies with efficacy endpoints, as discussed in several articles in the issue. Another possibility discussed in the issue is using model-informed drug development to optimize study design and analyses.

Other articles, the FDAers say, focus on characterizing the relationship between product quality characteristics and clinical performance to further streamline clinical development.

“We call on colleagues around the globe to continue to advance innovations in biosimilars to increase the availability of affordable, safe, and effective treatment options for patients,” the FDA authors conclude.