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

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.

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Reference

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