Evolving Biosimilar Clinical Requirements: A Qualitative Interview Study with Industry Experts and European National Medicines Agency Regulators
Druedahl, Louise C.; Kälvemark Sporrong, Sofia; van de Weert, Marco; De Bruin, Marie Louise; Hoogland, Hans; Minssen, Timo; Almarsdóttir, Anna Birna
(2021) BioDrugs, volume 35, issue 3, pp. 351 - 361
(Article)
Abstract
Background: A biosimilar is a biological medicine highly similar to another already approved biological medicine (reference product). The availability of biosimilars promotes competition and subsequently lower prices. Changing the current biosimilar clinical comparability trial requirements may lead to lower biosimilar development costs that potentially could increase patients’ access to biologics.
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Objective: The aim was to determine 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. Methods: Semi-structured interviews were conducted with eight European national medicines agency regulators and 17 pharmaceutical company employees or consultants with experience in biologics between September 2018 and August 2019. Data were subjected to content analysis. Results: In general, the participants expected that clinical comparability trial requirements will continue to be reduced, in particular based on advancements in analytical testing and knowledge generated from prior biosimilar approvals. However, there are also competing issues at play, such as competition, physician’s trust, and ethical considerations. Participants also reported that any new initiative to reduce or waive biosimilar clinical requirements needs to be scientifically sound and could potentially lower biosimilar development costs. Conclusion: The main findings are that biosimilar clinical comparability trial requirements are likely to change in the near future. Clarity is needed on how to ensure adequate correlation between physicochemical data, pharmacokinetic/pharmacodynamic studies, and the drugs’ performance in the clinic, as well as how to continue sufficient immunogenicity assessment. Obtaining this clarity can facilitate regulatory assessment of the next biosimilars.
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Keywords: Biosimilar Pharmaceuticals, Clinical Trials as Topic, Drug Approval, Humans, Taverne, Pharmacology (medical), Biotechnology, Pharmacology
ISSN: 1173-8804
Publisher: Adis International Ltd
Note: Funding Information: LCD was funded by a PhD fellowship grant to the University of Copenhagen from LEO Pharma A/S. LEO Pharma A/S was aware of, but had no decisive role in, the design or conduct of the study, collection, management, analysis, or interpretation of data, or the decision to submit the manuscript for publication. At the time of the study, MLDB was an employee of the Copenhagen Centre for Regulatory Sciences (CORS). CORS is a cross-faculty university anchored institution involving various public (Danish Medicines Agency, Copenhagen University) and private stakeholders (Novo Nordisk, Lundbeck, Ferring Pharmaceuticals, LEO Pharma) as well as patient organizations (Rare Diseases Denmark). The center is devoted to the scientific aspects of the regulatory field with a patient-oriented focus; its research is not company or product-specific; and it has received funding from LEO Pharma A/S for this project, as well as from Novo Nordisk, Ferring Pharmaceuticals, and Lundbeck for other projects not related to this study. Currently, MLDB is employed by Utrecht University as a senior researcher conducting research under the umbrella of the Center for Pharmaceutical Policy and Regulation. This center receives no direct funding or donations from private parties, including those in the pharmaceutical industry. Research funding from public–private partnerships, e.g., IMI, The Escher Project ( http://escher.lygature.org/ ), is accepted under the condition that no company-specific product or company related study is conducted. The center has received unrestricted research funding from public sources, e.g., World Health Organization (WHO), Netherlands Organization for Health Research and Development (ZonMW), the Dutch National Health Care Institute (ZIN), EC Horizon 2020, the Dutch Medicines Evaluation Board (MEB), and the Dutch Ministry of Health. TM’s work is supported by the Collaborative Research Program for Biomedical Innovation Law, a scientifically independent research program supported by the Novo Nordisk Foundation (Grant NNF17SA0027784). TM is a scientifically independent IP Advisory Board Member of the Danish Life Science Company Chr. Hansen A/S. The company had no role in the design or conduct of the study, collection, management, analysis, or interpretation of data; or the decision to submit the manuscript for publication. SKS, MvdW, HH, and ABA declare that they have no conflict of interest. Publisher Copyright: © 2021, The Author(s), under exclusive licence to Springer Nature Switzerland AG.
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