Approval of biosimilar epoetins: how similar are they?

Biosimilars/Research | Posted 24/09/2010 post-comment0 Post your comment

A consensus has emerged that approval of biosimilars requires both biological and clinical evidence. The ‘comparability exercise’ requires consideration of a wide range of aspects, including analytical and physico-chemical characterisation by several methods, comparative biological assays, comparative immunogenicity assessment, among others. The use of different host cells for the biosimilar product and the comparator in principle is possible.


Although required, a clinical programme for a biosimilar should have the primary aim of establishing ‘similarity’ and thus might be abridged compared with full clinical development of a new drug. The extent of studies required depends on the complexity of the product, its mode of action, its toxicity, the possible clinical effect of immunogenicity and the comparability of the response in different populations. See Table 1.

Table 1: Biosimilar erythropoietins approved in the EU in 2007

GW344-2 table

The high standards manufacturers of follow-up biologics have to meet require extensive investment in product testing, production and marketing. Consequently, the cost of protein drugs will continue to be relatively high.

Related article

Biosimilar epoetins: how similar are they?


Schellekens H. Biosimilar epoetins: how similar are they? Eur J Hosp Pharm. 2004;10(3):243-7.

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