It is at present unclear to what extent a further reduction of clinical comparability requirements would be acceptable, and therefore, Druedahl et al. [5] investigated the perceptions of industry and medicines agency regulators regarding the value, necessity and future developments of the European biosimilar clinical comparability trial requirements for establishing biosimilarity.

The study used qualitative interviews, in which the participating EU national medicines agency regulators and industry experts predicted that biosimilar clinical trial requirements for comparable efficacy would be further reduced in the near future. These predictions were based on, amongst others, the advancements in analytical testing of recombinant proteins and the knowledge generated from former biosimilar approvals.

Overall, the participants expressed scientific arguments for reducing the European biosimilar clinical trial requirements, which included that analytics and science were sufficiently developed and that clinical trials would be unethical if not scientifically justified. They said that the non-scientific consequences were that it would lower biosimilar development costs, making it attractive to develop biosimilars for more originator biologicals.

In general, the participants stated that scientific argument against reducing the European biosimilar clinical trial requirements was that it was necessary to conduct clinical trials to establish comparable efficacy and immunogenicity. They expressed that non-scientific consequences were that originator companies could become disincentivized if competition was introduced too easily and that physicians could become more reluctant to prescribe biosimilars.

Druedahl et al. concluded that there is a need for clarity on how to ensure adequate correlation between physicochemical data, pharmacokinetic/pharmacodynamics studies and the drugs’ performance in the clinic, as well as how to continue sufficient immunogenicity assessment. It is, however, likely that the European biosimilar clinical trial requirements will change in the near future.

Conflict of interest
The authors of the research paper have declared their funding and conflict of interest in the research paper [5].

Abstracted by Louise C Druedahl, MSc Pharm, PhD, Copenhagen Centre for Regulatory Science (CORS)/Centre for Advanced Studies in Biomedical Innovation Law (CeBIL), University of Copenhagen, Denmark.

Editor’s comment
Readers interested to learn more about the data requirements to demonstrate biosimilarity in the EU are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:

Data requirements to demonstrate biosimilarity in the EU

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Related article
Standardizing clinical trials for biosimilars

References
1. Allocati E, Bertele V, Gerardi C, Garattini S, Banzi R. Clinical evidence supporting the marketing authorization of biosimilars in Europe. Eur J Clin Pharmacol. 2020;76(4):557-66.
2. Frapaise FX. The end of phase 3 clinical trials in biosimilars development? BioDrugs. 2018;32(4):319-24.
3. Webster CJ, Wong AC, Woollett GR. An efficient development paradigm for biosimilars. BioDrugs. 2019;33(6):603-11.
4. Wolff-Holz E, Tiitso K, Vleminckx C, Weise M. Evolution of the EU Biosimilar Framework: Past and Future. BioDrugs. 2019;33(6):621-34.
5. Druedahl LC, Kälvemark Sporrong S, van de Weert M, De Bruin ML, Hoogland H, Minssen T, et al. Evolving biosimilar clinical requirements: a qualitative interview study with industry experts and European National Medicines Agency regulators. BioDrugs. 2021;35(3):351-61.

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