Regulatory overview of biosimilars in Europe

  • Jyothi Sri Durga Vanacharla Ms
  • Shailaja Pashikanti
  • Sowmya A. N. V. L


A biosimilar is a biological medicine similar, but not identical, to an already registered reference bio therapeutic product in terms of quality, safety, and efficacy. These drugs are also called as biosimilar products‘, follow-on protein products’ and subsequent-entry biologics‘. The EU has pioneered the regulation of biosimilar medicines by establishing a solid framework for their approval and by shaping biosimilar development globally. Since the EU approved the first biosimilar in 2006, healthcare professionals have gained increasing experience with their use. Today, biosimilars are an integral part of the effective biological therapies available in the EU, supported by adequate safeguards protecting patient safety. In Europe, in 2001, legislation concerning biosimilar was codified as Directive 2001/83/EC to create a new marketing authorization procedure for similar biological medicinal products and also Committee for Medicinal Products for Human Use (CHMP) of the EMA is concern with these biosimilar products. The aim of biosimilars development is to demonstrate bio similarity - high similarity in terms of structure, biological activity and efficacy, safety and immunogenicity profile. Safety of biosimilars is monitored through pharmacovigilance activities, in the same way as for any other medicine. Biosimilars can offer advantages to EU healthcare systems, as it is expected to improve patients’ access to safe and effective biological medicines with proven quality.

Keywords: Biosimilars, Marketing Authorization, EMA (European medical agency), CHMP (Committee for Medicinal Products for Human Use)


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1. Konangi S, Raviteja M, Gupta V. Comparison of global regulatory approvals for Biosimilar products. Int J Pharm Tech Res. 2013 Oct; 5(3):924-35.
2. European Medicines Agency. Guideline on similar biological medicinal products. CHMP/437/04 Rev 1 Committee for Medicinal Products for Human Use [Internet]. EMEA; 2014 Oct 23 [cited 2018 Jun 09]. Available from:
3. Strickland D, et al. Guide to biotechnology. Biotechnology Industry Organization, 2008 [Internet]. 2013 Nov 11 [cited 2018 Jun 13]. Available from: 008.pdf.
4. Sharma SK. Use of Biologics and Biosimilars in Rheumatology. The Journal of the Association of Physicians of India. 2017 May; 65(5):9-14.
5. The European Parliament and the Council of the European Union (2004) Directive 2004/27/EC & 2001/83/EC. In Official Journal of the European Union, L136 [Internet]. 2004 [cited 2018 Jun 23]; pp. 34–57. Available from:
6. Minocha S, Kakar A, Gogia A. Biosimilars: Aspirations and disappointments. Current Medicine Research and Practice. 2014 Sep 01; 4(5):242-6.
7. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: Quality issues (EMEA/CHMP/ 49348/05) [Internet]. EMEA; 2006 Feb [cited 2018 Jun 08]. Available from:
8. EMEA guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins (CHMP/ BMWP/14327) [Internet]. EMEA: London; 2007 [cited 2018 Jun 13]. Available from:
9. Therapeutic Goods Administration (TGA). Australian government, Department of Health [Internet]. TGA [cited 2018 Jul 03]. Available from:
10. Joung J, Robertson JS, Griffiths E, Knezevic I. WHO informal consultation on regulatory evaluation of therapeutic biological medicinal products held at WHO Headquarters, Geneva, 19–20 April 2007. Biologicals. 2008 Jul 01; 36(4):269-76.
11. Declerck P. Biologicals and Biosimilars: A review of the science and its implications. GaBI-Generics and Biosimilars Initiative Journal. 2012 Mar 01;1(1):13-6.
12. Volume 2A-Procedures for Marketing Authorization. Chapter 4, Centralized Procedure [Internet]. EMEA; 2006 Apr [cited 2018 Jul 10]. Available from: vol-2/a/chap4rev200604%20.pdf.
13. Biosimilars in the EU. Information guide for healthcare professionals. Prepared jointly by the European Medicines Agency and the European Commission [Internet]. EMEA; 2017 [cited 2018 Jun 22]. Available from:
14. European Medicines Agency - Marketing Authorisation - Biosimilar medicines: marketing authorization [Internet]. EMEA; 2018 [cited 2018 Jun 14]. Available from:
15. Blandizzi C, Meroni PL, Lapadula G. Comparing originator biologics and biosimilars: A review of the relevant issues. Clinical therapeutics. 2017 May 01; 39(5):1026-39.
16. Giezen TJ, Straus SM. Pharmacovigilance of biosimilars: challenges and possible solutions. GaBI J. 2012 Sep 01; 1(3-4):118-9.
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How to Cite
Vanacharla, J. S. D., S. Pashikanti, and S. A. N. V. L. “Regulatory Overview of Biosimilars in Europe”. International Journal of Drug Regulatory Affairs, Vol. 6, no. 3, Sept. 2018, pp. 40-44, doi:10.22270/ijdra.v6i3.270.