Nudging Biosimilars Closer to Fulfilling Their Promise in the United States

Will biosimilars improve public health? Policy makers should look to that question as they sort through possible solutions, the authors say.

There are several possible solutions to encouraging the use of biosimilars in the United States, according to a newly published article in the latest issue of the AMA Journal of Ethics.

While the authors hold out hope that some combination of new policies and regulatory changes will spur increased access and lower prices, interestingly, they also propose that if all else fails, perhaps it would then be time to regulate the prices of originator biologics after a certain period of exclusivity.

A similar argument has been made this year in a series of posts in Health Affairs, where some have called for regulating biosimilars in order to lower prices and increase access.

However, the political will to implement price regulation is scarce, notes the latest discussion on the topic, and so “encouraging increased competition in the biologics market with biosimilars remains the most promising mechanism to increase access to much-needed drugs,” the authors write.

Some of their recommendations, short of price regulation, include:

  • Passing legislation to increase the transparency in reporting of biologic patents, allowing biosimilar makers to more readily challenge their validity
  • Examining the anticompetitive practices of exclusionary contracts and arming regulatory agencies with increased power to act against such practices
  • Increase efforts at the FDA to educate physicians and the public about the bioequivalence of biosimilars and remove unnecessary naming policies that the authors say cause confusion; they cite the 4-letter suffixes given to biosimilars to differentiate them from originator products as 1 example

Acknowledging that some patients and physicians still have concerns about biosimilars, questioning safety and effectiveness, the authors say that postmarketing studies of biosimilars will continue to be necessary to evaluate these concerns. They note, however, that, so far, studies have found no meaningful safety and efficacy differences between a biosimilar and its respective originator biologic.

Will biosimilars improve public health? Policy makers should look to that question as they sort through possible solutions, the authors say. The high cost of biologics imposes a barrier to patient access and adherence; lower prices resulting from competition will reduce overall healthcare costs and could improve medication adherence, resulting in better health outcomes.


Zhai MZ, Sarpatwari A, Kesselheim AS. Why are biosimilars not living up to their promise in the US? AMA J Ethics. 2019;21(8):E668-678. doi: 10.1001/amajethics.2019.668.

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