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

reedbeall at gmail.com reedbeall at gmail.com
Tue Jun 18 14:06:52 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.


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


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 (
<mailto:Reed.Beall at ucalgary.ca> Reed.Beall at ucalgary.ca)

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