[Ip-health] New study finds no evidence that developing biologic drugs was more time-intensive than traditional small-molecule drugs

Reed Beall reed.beall at ucalgary.ca
Tue Jun 18 12:14:46 PDT 2019


NEW STUDY:                 Pre-market development times for biologic versus small-molecule drugs

PUBLICATION DATE:     18 June 2019 at 11AM (4PM BST)

JOURNAL:                      Nature Biotechnology

AUTHORS:                      Reed F. Beall, Thomas J. Hwang, and Aaron S. Kesselheim

ARTICLE ACCESS:           https://rdcu.be/bHble

Do biologic drugs take longer to develop than small molecule drugs? In the latest study from PORTAL published in Nature Biotechnology, we attempted to answer that question. US law currently provides a guaranteed minimum period of 12 years of market exclusivity for biologic drugs in part because it has been long believed that more complex biologic drugs take longer to develop than simpler small molecule drugs. This controversy has taken on international implications in recent years because the proposed revised NAFTA-called the US Mexico Canada Agreement-requires Canada and Mexico to lengthen the guaranteed minimum exclusivity periods they provide to biologics.

To estimate how long it takes to develop a biologic drug, we examined all new drugs approved by the FDA's Center for Drug Evaluation and Research over the last decade-a total of 275 small molecule and biologic products. We also used a novel methodological approach in which we estimated the drug development time as the period between the date of the first patent filing related to the drug and FDA approval. We found that among 212 (77%) small-molecule drugs and 63 (23%) biologic drugs, median total development times were not different between biologic and small-molecule drugs using data from the US Patent and Trademark Office. In linear regression models controlling for each expedited program separately and in multivariable models controlling for FDA development and review programs and other study variables, we observed no association between total development times for biologic versus small molecules.

We therefore found no evidence that developing biologic drugs was more time-intensive than traditional small-molecule drugs. Reed F. Beall, the study's lead author said: "Our study shows that biologic and small molecule drugs take similar amount of time to develop through clinical trials. Policies intended to extend exclusivity periods for biologics, as Canada is now doing due to the USMCA trade deal, should not be justified by pointing to longer pre-market development times for biologic drugs."

For more information or to request a copy of the study, contact Reed Beall (Reed.Beall at ucalgary.ca<mailto:Reed.Beall at ucalgary.ca>, 403.607.2323).

Reed F. Beall, Ph.D.
Assistant Professor
Community Health Sciences
Cumming School of Medicine & O'Brien Institute for Public Health
3280 Hospital Drive, TRW 3E46
Calgary, AB T2N 4Z6  Canada
Tel: 403.220.7452
Email: Reed.Beall at ucalgary.ca<mailto:Reed.Beall at ucalgary.ca>
Web: http://reed-beall.squarespace.com

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