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# Drug and Bio Development Times Similar: Analysis
- URL: https://www.fdaweb.com/drug-and-bio-development-times-similar-analysis/
- Published: 2019-06-18T12:00:00.000Z
- Updated: 2026-09-15T01:33:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144359

Researchers from Harvard Medical School and the University of Calgary say there are similar development times for small molecules and biologic drugs, leading to questions about the longer patent period under the Biologics Price Competition and Innovation Act. “Our study reviewed pre-market times for all new drugs approved by CDER over the past decade,” the authors write. “Although new laws are being considered by policymakers around the world to further expand market exclusivities for biologics, we found no evidence that developing biologic drugs was more time-intensive than developing traditional small-molecule drugs. In addition, biologic drugs appear to be associated with higher probabilities of success during clinical testing and regulatory approval than small-molecule drugs.”

The analysis suggests policymakers should prioritize eliminating barriers to biosimilar competition and continue to monitor the potential impact of varying exclusivity protections on biologic versus small-molecule drug development.

The study was [published](https://www.nature.com/articles/s41587-019-0175-2.epdf?author%5Faccess%5Ftoken=Rz-r6L5bUXevoyN4bFKTLNRgN0jAjWel9jnR3ZoTv0NN9acoKCgoHFaTFLj5Ud3S4kiyng1M7iZOmu7i-XVXShkPYrEpyCc%5FtM4LtKiHkOtlaGwqJaGQKJtwvJKfmrdJbNQ1dJ6i8SLoL3dN6BGdcQ%3D%3D&ref=fdaweb.com) online in the journal *Nature*.