Biosimilar uptake in the US market has, until now, stood in stark contrast to that in the EU, which has led the way in biosimilar approvals and use since 2006.

There are fundamental differences in both the regulatory processes and the market dynamics of the US and the EU that account for much of the discrepancy in the uptake of biosimilars

The main differences include:

  • The EU is several years ahead of the US with many blockbuster biologics reaching the market sooner and subject to competition from multiple biosimilars, resulting in falling prices and high biosimilar uptake. This is due to a difference in the patent landscape, with some EU patents ending earlier and some originator companies generating more patent barriers in the US.
  • In the US market, the FDA requirement is that biosimilars prove “interchangeability” with the originator before automatic pharmacy-level substitution is permitted. The EMA, on the other hand, does not have a specific “interchangeable” designation for biosimilars and has deferred all decisions on interchangeability, switching, and substitution to member states.
  • The EU has single-payer healthcare systems compared to the fragmentation of the US market, and therefore differences in acquisition practices and pricing. In the US, the key factor affecting biosimilar uptake is payers’ perception of safety and efficacy, as well as their management practices, which are driven by pricing and manufacturer rebates. In contrast, in the EU, biologics are often procured through tenders, and biosimilars often win by offering the lowest prices.

There are many signs, however, that the US is on the cusp of a major shift with respect to biosimilars: competitive pricing pressure, regulatory changes, payer policies, resolution of litigation issues and growing comfort with biosimilars will finally converge to drive strong adoption. 

The US can draw lessons from the experience of biosimilars in the EU. Firstly, biosimilar discounts will be steeper and net prices lower than many expect. Secondly, while market dynamics are different in the US, payers will put in place processes that encourage physicians to prescribe biosimilars, and biosimilars should succeed in capturing a significant share of the market. 

ICON provides clients with a fully integrated approach to the development and commercialistion of biosimilar medicines. Please contact us to learn more.

This blog is an edited version of “The US Biosimilars Market: Shaking the “Laggard” Label” which appeared in Contract Pharma on 5th May 2020. To view the full article, please visit