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[Biosimilars in the European Union: current situation and challenges]
Elena Wolff-Holz1, Martina Weise2
1Paul-Ehrlich-Institut (PEI), Paul-Ehrlich-Str. 51-56, 63225, Langen, Deutschland. Elena.Wolff-Holz@pei.de.
Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz
|October 9, 2020
Summary
Biosimilars increase patient access to biological therapies. This review examines biosimilar marketing authorizations, clinical trial roles, and interchangeability challenges in the EU.
Area of Science:
- Pharmaceutical Sciences
- Biotechnology
- Regulatory Science
Background:
- Biosimilars are highly similar to approved biopharmaceuticals, enhancing patient access to therapies often limited by cost.
- Since 2006, biosimilars have expanded from low-molecular products to complex monoclonal antibodies for autoimmune diseases and oncology.
- The biosimilar concept is applicable to various biologicals, including future developments in gene therapy and mRNA vaccines.
Purpose of the Study:
- To review the current status of biosimilar marketing authorizations in the European Union.
- To present the role of clinical trials in biosimilar development and approval.
- To discuss challenges in biosimilar development and perspectives on interchangeability.
Main Methods:
- Review of European Union marketing authorization data for biosimilars.
- Analysis of regulatory guidelines and scientific literature concerning clinical trials for biosimilars.
- Examination of studies and expert opinions on the interchangeability of biosimilars.
Main Results:
- Physicochemical and functional similarity can suffice for biosimilarity, reducing the need for extensive clinical trials in some cases.
- Switching patients between reference products and biosimilars, or between biosimilars, has generally been considered safe.
- Germany has implemented provisional decisions for economic-based switching of patients to biosimilars.
Conclusions:
- Further data collection and evaluation are needed regarding the interchangeability of biosimilars and real-world supply practices.
- The regulatory landscape for biosimilars continues to evolve, impacting development and market access.
- Understanding the challenges and future potential of biosimilars is crucial for healthcare systems.
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