The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) was signed into law on 23 March 2010 by President Barack Obama [2]. However, since then, the US has been rather slow on the biosimilars front. In the European Union (EU), a legal framework for approving biosimilars was established in 2003 and biosimilars have been approved by the European Medicines Agency (EMA) since 2006. There are currently 69 biosimilars approved in Europe, almost all of which were marketed immediately after approval [3].

In contrast, as of January 2021, the US Food and Drug Administration (FDA) had only approved 29 biosimilars [4], with only 18 so far having been launched in the country [5], see Table 1.

But what is the cause of this discrepancy between the US and Europe and why are so many biosimilars still not marketed in the country? One reason could be market differences. Europe differs from the US in three ways:

1) Maturity of the market
The first biosimilar Omnitrope (somatropin) was approved in Europe in 2006 [3]. While in the US the first biosimilar Zarxio (filgrastim-sndz) was only approved in 2015 [5]. In addition, 11 of the 18 biosimilars marketed in the US were only launched since January 2019. Although, that being said, Europe has approved more than half of its biosimilars since 2017.

2) Number of competitors
Europe has approved more biosimilars for almost every active ingredient. Take the examples of filgrastim and pegfilgrastim. In the EU, there are seven filgrastim biosimilars and eight pegfilgrastim biosimilars approved [3]. Whereas in the US, there are only two filgrastim biosimilars and four pegfilgrastim biosimilars approved, with one pegfilgrastim biosimilar yet to be marketed, see Table 1. In contrast, however, FDA does have 30 biosimilar applications in review compared to only 12 in review at EMA [6].

3) Biosimilar market share
Biosimilar uptake in the US has been slow. While the first biosimilar Zarxio has managed to gain almost 55% of the US filgrastim market, an analysis of healthcare plans’ coverage found that only 14% of decisions gave preferred coverage to the biosimilar.

The situation in Europe often varies markedly between different countries, especially since decisions on interchangeability are taken at a Member State level [7]. Some countries have high biosimilar uptake while others lag behind. For example, 16 European countries achieved biosimilar use of more than 90% for filgrastim and pegfilgrastim in 2018, but in Ireland this was just 27%. Again, for antitumour necrosis factor biosimilars (adalimumab, etanercept and infliximab), Norway and Denmark had 81% and 96% biosimilar uptake, respectively, but uptake in all other countries was below 50%.

The authors therefore concluded that ‘the European biosimilars market as a whole is not markedly different from the US market after accounting for its longer existence. That said, there are certainly lessons the US can draw from Europe’s experience – both cautionary lessons and ones we should follow’.

Related articles
Price controls, competition and tendering for biosimilars

What can the US learn from the European biosimilars market?

References
1. Biosimilars Council. Brill A, Robinson C. Lessons for the United States from Europe’s biosimilar experience. June 2020 [homepage on the Internet]. [cited 2021 Feb 5]. Available from: https://biosimilarscouncil.org/resource/europes-biosimilar-experience/
2. GaBI Online - Generics and Biosimilars Initiative. The evolution of biosimilars in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Feb 19]. Available from: www.gabionline.net/Reports/The-evolution-of-biosimilars-in-the-US 
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Feb 19]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe 
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Feb 19]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US 
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilar approvals and launches in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Feb 19]. Available from: www.gabionline.net/Biosimilars/General/Biosimilar-approvals-and-launches-in-the-US 
6. GaBI Online - Generics and Biosimilars Initiative. Biosimilars applications under review by EMA – January 2021 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Feb 19]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-applications-under-review-by-EMA-January-2021 
7. GaBI Online - Generics and Biosimilars Initiative. Biosimilars and interchangeability [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Feb 19]. Available from: www.gabionline.net/Biosimilars/Research/Biosimilars-and-interchangeability

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