Observations on the introduction of biosimilar epoetins into Europe

Biosimilares/Investigación | Posted 12/08/2011 post-comment0 Post your comment

Professor Wolfgang Jelkmann of the University of Luebeck in Germany has recently published a review article summarising the experiences with biosimilars introduced in the EU after the original biopharmaceutical patents expired [1].

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Focussing on the haematopoietic treatments, specifically the epoetins and filgrastims, Professor Jelkmann notes that the current nomenclature of the epoetins is confusing.

Several biosimilar recombinant human erythropoietin (rhEPO, also known as epoetin alfa) have been launched in the EU and the International Non-proprietary Names (INNs) and various brand names that exist for these products are causing not a little confusion. In some European countries, physicians are required to use the INN when prescribing. Therefore, when biosimilar products are allowed to have the same INN as the reference product, safety issues present themselves for the patient. For example, in the case of an adverse event, it is necessary to identify the drug that was deemed responsible by reporting the INN, the brand name and the relevant batch numbers.

A second observation is that, due to the price of the biosimilars being ~25–30% less than the originator, the launch of the less expensive biosimilar epoetins has led to some of the innovator companies reducing the price of their products.

Have you made any observations on the introduction of biosimilars into the market? Please feel free to contact us at editorial@gabionline.net or leave a comment below.

If you are interested in contributing a research article in a similar area to the GaBI Journal, please send us your submission via science@gabi-journal.net.

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Reference

1. Jelkmann W Biosimilar epoetins and other ‘follow-on’ biologics: Update on the European experiences. Am J Hematol. 2010; 85:771-80.

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