The report, which was carried out at the request of the European Commission, contains data covering the pandemic from June 2020 to June 2021.

The report found that 2020 was a particularly challenging year to launch non-COVID originator biologicals. In European markets the COVID-19 pandemic affected the ability of Pharma companies to launch new and switch prescriptions and to carry out face-to-face interactive engagement with healthcare professionals, both of which had an impact on uptake.

However, from a regulatory standpoint, the European Medicines Agency (EMA) continued to perform well approving both originator biologicals and biosimilars. In fact, the agency approved a total of nine biosimilars in 2020, and there are a further 13 products under review [2] to add to the 10 already approved to date (January 2022) [3].

Although new approvals of biologicals and biosimilars have not been affected the report found that there was a clear affect on the prescribing of biologicals. The reduction in prescribing was found to be up to -40% (for fertility) at its peak. Reasons for this were due to the prioritization of COVID-19 patients, intensive care and chronic conditions during the first lock-down in Europe.

One major concern raised from the lack of biologicals prescribing has been the effect on oncology, with delays in surgeries and chemotherapy and fewer diagnoses being conducted. Although this segment has returned, the impact on the healthcare system of patients with more advanced cancers will have a knock-on impact on mortality without effective management.

Conflict of interest
The authors of the report [1] did not provide any conflict-of-interest statement.

Editor’s comment
Readers interested to learn more about COVID-19 biologicals and biosimilars are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:

Biotechnological therapies and biosimilars for COVID-19: scarcities, poor regulation, and pharmaceutical black market: a case analysis in Ecuador

GaBI Journal is indexed in Embase, Scopus, Emerging Sources Citation Index and more.

Readers interested in contributing a research or perspective paper to GaBI Journal – an independent, peer reviewed academic journal – please send us your submission here.

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References
1. Troein P, Newton M, Scott K, et al. The impact of biosimilar competition in Europe: December 2021. IQVIA.
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars applications under review by EMA – January 2022 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Mar 4]. Available from: www.gabionline.net/biosimilars/general/biosimilars-applications-under-review-by-ema-january-2022
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Mar 4]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-europe

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