Europe has almost 15 years of experience with biosimilars, during which time it has gathered a huge amount of clinical data showing that biosimilars are safe and effective. In fact, a review of 178 studies comprising up to 21,000 switched patients in a variety of therapeutic areas, found that the vast majority of available data did not signal any major differences in clinical efficacy, safety or immunogenicity related to switching [2].

Other evidence includes studies in Norway and Denmark, where biosimilar uptake exceeds 80%, and ‘no unexpected issues have been discovered after more than a decade’. The Norwegian Medicines Agency added filgrastim to the substitution list back in 2010 [3]. In Germany, a new law is in the process of being implemented to allow for biosimilar substitution at the pharmacy level – an indication of confidence in biosimilars. While the Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA) recently published an analysis examining the safety of biosimilars in order ‘to help citizens and healthcare professionals in the use of these medicines, improving their understanding of therapeutic efficacy and the possibility of switching between biological therapies’.

The US Food and Drug Administration (FDA) finally issued its draft guideline on the interchangeability of biosimilars with their reference biologicals in 2017 [4]. The final guidance on interchangeable biologicals was then issued in May 2019 [5]. No interchangeable biosimilars have to date been approved in the US. Only one company, Boehringer Ingelheim, is known to be actively pursuing interchangeability, having publicly disclosed that it has started an interchangeability study for its proposed adalimumab biosimilar [5].

Although the US is 10 years behind Europe in generating clinical data on biosimilars, it does still have evidence to support switching to biosimilars. For example, the integrated healthcare system Kaiser Permanente recently published a study detailing the successful switch of adult patients with inflammatory bowel disease from the reference biological Remicade to an infliximab biosimilar. Kaiser has also managed to achieve 80% use of bevacizumab, infliximab, filgrastim and rituximab biosimilars, in some cases within weeks.

FDA is also committed to sharing data with Europe, a plan that it has set out in its Biosimilar Action Plan. The agency released its Biosimilars Action Plan in July 2018, with the aim of improving the efficiency of the biosimilar and interchangeable product development and approval process [6]. There have been, however, attempts in the US to undermine the clinical evidence on biosimilars from Europe. FDA has recently teamed up with the Federal Trade Commission to fight misinformation about biosimilars. In fact, Pfizer brought the subject to the attention of FDA back in 2018, when the pharma giant pointed to multiple communications from reference product sponsors that were misleading [7]. Deliberate misinformation has been linked with causing confusion and doubt about biosimilars in patients and physicians and to contribute to the sluggish US biosimilars market [8].

Related articles
Targets and incentives to encourage use of biosimilars

Education for biosimilars in Europe and the US

Price controls, competition and pricing for biosimilars

How do the biosimilar markets in the US and Europe compare?

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 Mar 19]. Available from: https://biosimilarscouncil.org/resource/europes-biosimilar-experience/ 
2. GaBI Online - Generics and Biosimilars Initiative. Safety of switching between reference products and biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Mar 19]. Available from: www.gabionline.net/Biosimilars/Research/Safety-of-switching-between-reference-products-and-biosimilars 
3. GaBI Online - Generics and Biosimilars Initiative. The evolution of switching and substitution of biosimilars in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Mar 19]. Available from: www.gabionline.net/Reports/The-evolution-of-switching-and-substitution-of-biosimilars-in-Europe 
4. GaBI Online – Generics and Biosimilars Initiative. FDA issues draft guidance on biosimilar interchangeability [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Mar 19]. Available from: www.gabionline.net/Guidelines/FDA-issues-draft-guidance-on-biosimilar-interchangeability 
5. GaBI Online – Generics and Biosimilars Initiative. FDA issues final guidance on interchangeable biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Mar 19]. Available from: www.gabionline.net/Guidelines/FDA-issues-final-guidance-on-interchangeable-biologicals 
6. GaBI Online – Generics and Biosimilars Initiative. FDA releases guidances and proposed rule to advance biosimilars policy framework [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Mar 19]. Available from: www.gabionline.net/Guidelines/FDA-releases-guidances-and-proposed-rule-to-advance-biosimilars-policy-framework 
7. GaBI Online – Generics and Biosimilars Initiative. FDA guidance sought on false and misleading information on biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Mar 19]. Available from: www.gabionline.net/Biosimilars/General/FDA-guidance-sought-on-false-and-misleading-information-on-biosimilars 
8. GaBI Online – Generics and Biosimilars Initiative. The sluggish US biosimilars market [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Mar 19]. Available from: www.gabionline.net/Reports/The-sluggish-US-biosimilars-market%20

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