All medicines carry the risk of unwanted side effects. The decision to prescribe a certain medicine will be based on a favourable risk-benefit ratio. When generic versions of protein drugs were allowed on the market, there was concern regarding the safety of these biosimilar medicines (in particular, immunogenicity). Since November 2005, the European Medicines Agency (EMA) requires a Risk Management Plan as part of a marketing application for all new medicines and biosimilars. In oncology, 2 biosimilars are of particular interest: G-CSF and erythropoietin, and all licensed products have a risk management plan in operation. Although the plans and results are confidential, it is assumed that no serious unexpected events have been reported, as no regulatory actions have been taken by EMA with these products. With the positive experience of the smaller protein biosimilars, we can look forward with confidence to the next challenge: biosimilar monoclonal antibodies. Risk management plans will play an important role in assuring doctors and patients on the safety of biosimilars, increasing thereby their acceptance with potentially a reduction in drug cost for the society.

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Keywords Biosimilar, G-CSF, Risk management, drug approval, drug safety, erythropoietin
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Journal Oncologie
Vulto, A.G. (2011). Risk management of biosimilars in oncology. Oncologie, 13(5), 196–200. doi:10.1007/s10269-011-2016-x