Licensing of biosimilars in Europe

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How is licensing of biosimilars actually being applied in Europe? This was the question broached in a paper by Dr Christian Schneider – Chairman of both the Committee for Advanced Therapies and Biosimilar Medicinal Products Working Party and Co-opted member of the Committee for Medicinal Products for Human Use (CHMP).


Licensing of biosimilar products has been possible in Europe since a regulatory framework for similar biological medicinal products was established and there was a positive opinion by the EMA’s CHMP for the first biosimilar products (human growth hormones Omnitrope and Valtropin; brand names for somatropin).

Dr Schneider and Dr Kalinke put forward that the limited experience gained so far from biosimilar approvals has proved the following:

  • Implementation of guidelines for the development of biosimilars is possible. This was disputed earlier, particularly by innovator companies.
  • The ‘comparability exercise’ requires consideration of a wide range of aspects, including analytical and physicochemical characterisation by several methods, comparative biological assays, and comparative immunogenicity assessment, among others.
  • The use of different host cells for the biosimilar and the comparator is possible, as was shown in the case of the human growth hormone biosimilar, Valtropin (somatropin).
  • The comparator product must be approved in the EU and should not be changed during development.
  • The clinical programme for a biosimilar should establish ‘similarity’ and may therefore be reduced compared to the full clinical development required for a new drug.

The authors concluded that European guidelines introduce the general concept of biosimilars. The guidelines mention ‘any biological product’, and include complex biotech-derived medicinal products, such as immunologicals (vaccines), blood products and monoclonal antibodies (mAbs), thus opening the door for a whole new generation of biosimilars.

(see also Will the EU biosimilars pathway be applicable to monoclonal antibodies?, Development of biosimilars mAbs and Challenges in the development of biosimilars mAbs)


Schneider CK, Kalinke U. Toward biosimilar monoclonal antibodies. Nat Biotechnol. 2008;26(9):985-90

EMA, Committee for medicinal products for human use (CHMP), Guideline on similar biological medicinal products, CHMP/437/04, London, 30 October 2005

EMA, Omnitrope European Public Assessment Report (EPAR) H-C-607, 23 April 2008

EMA, Valtropin European Public Assessment Report (EPAR) H-C-602, 17 June 2009

European Commission (EC). Directive 2001/83/EC of the European parliament and of the council of 6 November 2001 on the community code relating to medicinal products for human use. Off J Eur Comm. 2004; L-311, 67–128

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