New Questions Arise About the Need for Lengthy Biologic Exclusivity Periods

Biologic drugs, by virtue of their complexity, are time-consuming and expensive to develop. As such, exclusivity periods for biologics were set at 12 years in the Biologics Price Competition and Innovation Act.

While it is generally accepted that such exclusivity periods allow drug makers to reap the rewards of their innovation and recoup their costs, a study published this week in Nature Biotechnology calls into question whether innovator drugs’ development timelines truly warrant these long exclusivity periods that preclude biosimilar competition.

The study’s authors compared key patent filing dates associated with small-molecule drugs and biologics to determine whether there was any difference in the amount of time these products spent in development prior to FDA approval. They found that, between 2007 and 2016, the FDA approved 212 small-molecule products and 63 biologics, and key patents could be identified for 92% of these products using United States Patent and Trademark Office (USPTO) data.

Across these products, the median total development times, measured from first patent filing to FDA approval based on USPTO data, were 12.4 years (interquartile range, 9.7-15.3). Total development times were similar between small-molecule drugs and biologics, with median preclinical development times, using USPTO data, falling at 3.3 and 3.7 years for small molecules and biologics, respectively (P = .91).

Using data from the Merck Index, biologics had shorter preclinical development times than small molecules, at 2.2 years for biologics versus 4.0 years for small molecules (P = .002)

When controlling for expedited programs, the investigators observed no association between total development times for biologics versus small molecules using USPTO data. Using data from the Merck Index, biologics were again associated with shorter development times.

According to the authors, while biologics are often believed to be more time consuming to develop than small-molecule drugs, development times are in fact similar between these 2 drug types.

“Although new laws are being considered by policymakers around the world to further expand market exclusivities for biologics,” write the authors, “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 authors also note that other research has demonstrated that biologics are associated with higher probabilities of success in clinical testing and regulatory approval than small-molecule drugs. Taken together, these findings suggest that policy makers should eliminate barriers to biosimilar competition and monitor the impacts of varying exclusivity protections on novel drug development.

Reference

Beall RF, Hwang TJ, Kesselheim AS. Pre-market development times for biologic versus small-molecule drugs [published online June 18, 2019]. Nature Biotechnol. doi: 10.1038/s41587-019-0175-2.