European regulatory framework for approval of biosimilars – perspectives and future developments

Biosimilars/Research | Posted 15/02/2019 post-comment0 Post your comment

Regulatory agencies around the world have reviewed and approved marketing authorization applications for biosimilars via specific marketing authorization procedures that vary between jurisdictions. In Europe, the European Medicines Agency (EMA) has already more than 10 years of experience with review of applications and approval of biosimilars for use in the European Union.


This triggered Moorkens et al. [1] to discuss the current European regulatory framework, and how this is perceived by stakeholders not directly involved in the marketing authorization process. In this article, future developments and possible improvements are also considered.

As the use of biosimilars in Europe has not indicated occurrence of adverse events different from those with the reference biological product, the specific marketing authorization procedure for biosimilars in Europe can be deemed suitable to assess evidence on quality, safety and efficacy of the biosimilar. One of the strengths of the European system is a transparent approach, where different stakeholders are included for shaping guidelines. This has contributed to the acceptance of biosimilars in Europe.

However, despite information on decisions of EMA via assessment reports and efforts of EMA and European Commission to educate stakeholders on biosimilars, it is often difficult for physicians, pharmacists and patients to understand the biosimilar pathway. To resolve this, regulators should work on a good communication strategy to reach the target audience, as it seems that the problem is not a lack of information. This might prove highly important as it is suggested that phase III clinical trials may become less important for demonstrating biosimilarity. Furthermore, it is valuable to discuss guidelines between regulatory agencies in different jurisdictions since this might contribute to increased scientific capacity and facilitate global development of biosimilars, reducing costs, while maintaining high quality standards.

Conflict of interest
The authors of the research paper [1] reported conflicts of interest, including having conducted biosimilar research sponsored by Hospira (now Pfizer) and being involved in consulting, advisory work and speaking engagements for a number of companies, including, AbbVie, Amgen, Biogen, EGA, Pfizer/Hospira, Mundipharma, Roche, Sandoz.

For full details of the authors’ conflict of interest, see the research paper [1].
Abstracted by Evelien Moorkens, PhD Researcher Market Access Biosimilars, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Belgium.

1. Moorkens E, Vulto A, Huys I. Regulatory frameworks for marketing authorisation of biosimilars: where do we go from here? European Pharmaceutical Law Review. 2018;2(3):149-54. doi:10.21552/eplr/2018/3/6

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2019 Pro Pharma Communications International. All Rights Reserved.

comment icon Comments (0)
Post your comment
Related content
Clinical development of biosimilars in the oncology setting
Cancer image015
Biosimilars/Research Posted 17/09/2021
Knowledge and perceptions of naming for biosimilars in the US
Naming 1 V13I27
Biosimilars/Research Posted 10/09/2021
New quality-range-setting method for biosimilarity assessment
127 AA010925
Biosimilars/Research Posted 10/09/2021
Most viewed articles
About GaBI
Home/About GaBI Posted 05/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010