PerspectiveDRUG DEVELOPMENT

Are trade secrets delaying biosimilars?

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Science  10 Apr 2015:
Vol. 348, Issue 6231, pp. 188-189
DOI: 10.1126/science.aab1684

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Summary

On 6 March 2015, the United States Food and Drug Administration (FDA) approved, under the Biologics Price Competition and Innovation Act (BPCIA), a biosimilar of filgrastim (Neupogen), for treating chemotherapy-caused neutropenia (1). Although this action represents a step toward cheaper medical treatments, it masks systemic problems. Not only has it taken 5 years since the BPCIA's passage (2), but economists estimate that even by 2020, biosimilar competition will reduce consumer prices only modestly (3). Why will price competition be so lacking? One key reason is the barrier to competitive entry created by trade secrecy in biologics manufacturing.