Opportunities and challenges with biosimilars

As the patents on many biopharmaceuticals are expiring, biosimilars have become an issue of major importance. This publication contributes to the ongoing discussion, presenting the lectures of a symposium on biosimilars held during the 25th Annual Meeting of the International Society of Blood Purification in Prague in 2007. The first presentation looks at the differences in the economic situation and renal health care in the ‘old’ and ‘new’ countries of the European Union, and the potential impact of this difference on the attitude to the use of biosimilars. Stressing the elaborate production processes, the next contribution suggests that biopharmaceuticals (including biosimilars) produced by different companies cannot be identical, and that their safety and efficacy must therefore be carefully assessed. This is followed by a paper on the risk of unexpected immunogenicity caused by apparently not significant changes in the manufacturing process, and an analysis of the current state and the implications of the problems raised by the introduction of biosimilars concludes the discussions.