Dr Pekka Kurki
Biosimilar Nederland presented Dr Pekka Kurki with the Van der Does Award for his lifelong contribution to rational, science driven cost-effective therapies on 25 May 2023.

From its advent, Dr Pekka Kurki has been involved in laying the foundation for a biosimilar regulatory framework. He is now regarded as one of the founding fathers of biosimilars in Europe, playing a major role in setting the regulatory standards that we see the benefits of today.

Dr Kurki graduated as a medical doctor in 1975 from Helsinki University and pursued a clinical research career in academia and in industry (Sandoz). Dr Kurki started his regulatory work in 1997 at the Finish Medicines Agency. From 1998–1999 he was a member of the European Medicines Agency (EMA) Biologicals Working Party, and from 2000–2007 a Committee for Medicinal Products for Human Use (CHMP) member. His membership of the Working Party for comparability of biologicals from 2002–2003 was instrumental and after this, he became chair of the Biosimilar Working Party (2004–2007) where he stayed on as an expert until 2018. Although he retired from the agency in 2016, he remains active in discussing and publishing on biosimilars. Throughout his career, Dr Kurki has shared his wisdom with young researchers and has given them the honour of being first author on seminal publications.

Dr Kurki was not only inward looking as a regulator, but was also active in disseminating messages to a wider audience. Soon after the foundation of GaBI, he joined the scientific advisory board and in January 2016 he chaired the GaBI multi-stakeholder Roundtable on Biosimilars in Brussels with the meeting report published in GaBIJ with over 13,900 manuscript views [1], with the conclusion that ‘Different stakeholders – patients, doctors, pharmacists, payers – need different information. Above all, this must be a collaborative exercise’.

He has published widely on biosimilars [2-5] and he ended the debate on potential immunogenicity issues related to biosimilars in his pivotal review [6], scrutinising all patient data submitted to EMA where he concluded:

‘This is the first study to comprehensively analyze postmarketing surveillance data of the biosimilar mAbs and etanercept. An analysis of more than 1 million patient-treatment years of safety data raised no safety concerns. Based on these data, we argue that biosimilars approved in the EU are highly similar to and interchangeable with their reference products. Thus, additional systematic switch studies are not required to support the switching of patients.’

Dr Kurki’s way of thinking is considered science-driven and forward looking as is demonstrated by recent role in to the revision of the World Health Organization (WHO) guidelines on the evaluation of biosimilars [7].

Van der Does Award
The Van der Does Award for rational and cost-effective drug treatment was set up in honour of Emiel van der Does, a general practitioner and professor of General Practice at the Erasmus University in Rotterdam. Following his passing in 2018, Biosimilars Nederland founded the award in his honour due to his contribution to the constructive critical attitude of many doctors and pharmacists towards medicines, promoting rational and cost-effective treatment.

References
1. Annese V, Avendaño-Solá C, MD, Breedveld F, et al. Roundtable on biosimilars with European regulators and medical societies, Brussels, Belgium, 12 January 2016. Generics and Biosimilars Initiative Journal (GaBI Journal). 2016;5(2):74-83. doi:10.5639/gabij.2016.0502.019
2. Kurki P. No need for systematic switch studies to demonstrate interchangeability of biosimilars. Generics and Biosimilars Initiative Journal (GaBI Journal). 2022;11(1):5-6. doi:10.5639/gabij.2022.1101.002
3. Kurki P. EU Member States have tools to reduce costs of bestseller biologicals but can they use them? Generics and Biosimilars Initiative Journal (GaBI Journal). 2018;7(1):5-7. doi:10.5639/gabij.2018.0701.002
4. Kurki P. Potential changes to the FDA approach to biosimilars have a global impact. Generics and Biosimilars Initiative Journal (GaBI Journal). 2018;7(2):53-5. doi:10.5639/gabij.2018.0702.011
5. Kurki P. Physicians, Hippocrates and biosimilars: applying ancient principles in a modern society. Generics and Biosimilars Initiative Journal (GaBI Journal). 2016;5(4):149-50. doi:10.5639/gabij.2016.0504.039
6. Kurki  P, Barry S, Bourges I, et al. Safety, immunogenicity and interchangeability of biosimilar monoclonal antibodies and fusion. Drugs. 2021;81(16):1881-96.
7. World Health Organization. Guidelines on evaluation of biosimilars [homepage on the Internet]. [cited 2023 Jun 19]. Available from: https://www.who.int/publications/m/item/guidelines-on-evaluation-of-biosimilars

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