In Europe, the European Medicines Agency (EMA) has shown itself to be open to the evolution of the biosimilars pathway and to be willing to work with industry as the biosimilars market matures to streamline its application and approval processes.

EMA revised its overarching biosimilars guidelines in 2014. The updated guidance, which came into effect in 2015, allows clinical trials conducted using reference medicines authorised outside the European Economic Area (EEA) to be used for the European biosimilar application [2]. In the past, these trials would have had to be repeated in European patients, using a Europe-approved reference medicine, at extra cost to the sponsor. In fact, the agency announced back in 2012 that it had adapted its guidance to allow it to accept clinical data from biosimilars approved outside the EEA [3].

EMA has also shown itself to be open to alternative clinical development strategies for biosimilars. Companies that aim to deviate from regulatory guidelines can use the scientific advice procedure of EMA. Experience from the past has shown that deviations might be accepted if they can be scientifically justified. Use of such procedures may have led EMA to accept non-inferiority, rather than standard equivalence designs, for biosimilarity trials with rituximab [4].

The US Food and Drug Administration (FDA) also appears to recognize the need to evolve standards over time. The director of the agency’s Office of Therapeutic Biologics and Biosimilars, Dr Sarah Yim, recently acknowledged that they should move away from thinking about ‘clinical studies for every biosimilar development program’. While a review of European Union and US biosimilar approvals found that there is ‘no routine need for comparative efficacy trials’.

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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 26]. Available from: https://biosimilarscouncil.org/resource/europes-biosimilar-experience/ 
2. GaBI Online - Generics and Biosimilars Initiative. EMA issues revised version of overarching biosimilars guideline [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Mar 26]. Available from: www.gabionline.net/Guidelines/EMA-issues-revised-version-of-overarching-biosimilars-guideline 
3. GaBI Online - Generics and Biosimilars Initiative. EMA to accept biosimilar reference medicines from outside EEA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Mar 26]. Available from: www.gabionline.net/Guidelines/EMA-to-accept-biosimilar-reference-medicines-from-outside-EEA 
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilarity testing using very low doses of rituximab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Mar 26]. Available from: www.gabionline.net/Biosimilars/Research/Biosimilarity-testing-using-very-low-doses-of-rituximab

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