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Business & Regulation Trends & Forecasts

The Key to Competition

A study of 264 small molecule drugs facing generic competition from 2012–2018 (1) found that exclusivity periods were shorter compared with four biologics (14.2 vs 16.6 years). The research team from Brigham and Women’s Hospital also found that exclusivity periods were shorter in cases where the first generic was granted 180 days of exclusivity (14.1 vs 15.9 years) – an incentive designed to expedite generic competition.

Modified versions of existing products, including those with novel routes of administration, therapeutic areas, or use of expedited approval pathways, had shorter exclusives than new drugs, too (9.9 vs 14.5 years). But, in contrast to some previous estimates, the team did not find that exclusivity periods for small molecules were lengthening.

The authors hope the findings will inform policymakers as they consider options to encourage timely competition. Most importantly, they warned in their paper that “Unnecessarily long exclusivity periods delay patient access to lower-priced medications.”

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  1. BN Rome et al., “Market Exclusivity Length for Drugs with New Generic or Biosimilar Competition, 2012-2018” (2020). Available at: https://bit.ly/3ij8Vcy.

About the Author

James Strachan

Over the course of my Biomedical Sciences degree it dawned on me that my goal of becoming a scientist didn’t quite mesh with my lack of affinity for lab work. Thinking on my decision to pursue biology rather than English at age 15 – despite an aptitude for the latter – I realized that science writing was a way to combine what I loved with what I was good at.

From there I set out to gather as much freelancing experience as I could, spending 2 years developing scientific content for International Innovation, before completing an MSc in Science Communication. After gaining invaluable experience in supporting the communications efforts of CERN and IN-PART, I joined Texere – where I am focused on producing consistently engaging, cutting-edge and innovative content for our specialist audiences around the world.

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