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# Newer Approach Could Help Biosimilar Development: FDA
- URL: https://www.fdaweb.com/newer-approach-could-help-biosimilar-development-fda/
- Published: 2026-11-10T17:23:31.000Z
- Updated: 2026-11-10T17:23:31.000Z
- Author: David McFarland
- Tags: Biologics

FDA researchers say there have been global efforts to streamline biosimilar development of therapeutic proteins (TPs) by reducing reliance on comparative efficacy studies and moving instead toward a comparative analytic assessment plus pharmacokinetics approach. Writing in the open-source *Clinical Pharmacology & Therapeutics*, the researchers say the new approach is expected to be applicable across a wide range of therapeutic proteins, “potentially lowering the development burden and facilitating broader biosimilar approvals.”

The researchers reviewed the product labeling and FDA approval summaries for the 282 TPs approved as of 4/2026 to identify those with limited systemic exposure and explore potential challenges for conducting a comparative efficacy study. They found 19 TPs with limited systemic exposure, of which 15 were well-characterized. Some 12 of the 15 had at least one comparative efficacy study-feasible indication. The authors say the remaining three TPs may require alternative strategies, including pharmacodynamic biomarker approaches or optimized comparative efficacy study designs, “underscoring the need for proactive regulatory engagement.”

The authors conclude that for TPs with limited systemic exposure, a comparative clinical study (pharmacodynamic similarity study or comparative efficacy study) remains the most appropriate approach. But when suitable pharmacodynamic biomarkers are available, they say, the comparative analytical assessment plus pharmacodynamics approach could improve the efficiency of biosimilar development compared with the comparative analytical assessment plus comparative efficacy study approach.