In the US, a legal framework for approving biosimilars was established in 2009, via the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The US Food and Drug Administration (FDA) approved its first biosimilar, Zarxio (filgrastim-sndz), in 2015 [2]. To date, FDA has approved 29 biosimilars [3]. However, only nine of these approved biosimilars are on the market. 

In Europe a legal framework for approving biosimilars was established in 2003. The European Medicines Agency (EMA) approved its first biosimilar, Omnitrope (somatropin) in 2006 [4]. In contrast to the US, a whopping 54 biosimilars are approved for use in Europe, almost all of which are already marketed [5]. 

In fact, biosimilars currently make up only 2.3% of the US biologicals marketplace. Currently, 90% of global biosimilars sales take place in Europe, despite 60% of overall biologicals sales occurring in the US. 

Ms Reed asks in her presentation ‘what is preventing a robust US biosimilars’ market?’ She concludes that anti-competitive behaviours and other market and regulatory dynamics currently discourage market uptake of biosimilars in the US. These include:

• Deliberate misinformation, which has sown confusion and doubt with patients and physicians
• Exclusionary contracting and rebate practices, fuelled by misinformation
• Limited reliance on global biosimilar experience and successes
• Patent litigation and thickets
• Length of time from FDA approval to market launch

This, according to Ms Reed, leads to delayed uptake of biosimilars, which in turn forestalls savings.

Biologicals account for less than 1% of prescriptions filled but equal close to one-third of all drug spending. They are the single biggest driver of Medicare drug spending. Biosimilars on average can cost 30% less than reference biologicals, with the potential to save the US up to US$71 billion in the next decade. In fact, the US could save US$7.2 billion annually if the biosimilars marketplace grew to 75%, and even more savings could be realized if more classes of biosimilars are approved. 

The loss is also not only to the US government, patients are also suffering. Former FDA Commissioner Scott Gottlieb stated that ‘if Americans had the opportunity to purchase successfully marketed, FDA-approved biosimilar prescription drugs, they could have saved more than US$4.5 billion in 2017’.

Ms Reed concludes that the only way for the US to change this scenario is to implement measures to support a viable US biosimilars market.

Ms Reed covers in more detail how to support a viable US biosimilars market in the article that follows.

Related article
How to support a viable US biosimilars market

References
1. Reed J. The State of the Biosimilars Market. DIA Biosimilars Conference; Bethesda, Maryland, US; 23-24 September 2019.
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves its first biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Nov 29]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-its-first-biosimilar
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Nov 29]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars use in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Nov 29]. Available from: www.gabionline.net/Reports/Biosimilars-use-in-Europe
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Nov 29]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe

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