• H Mellstedt.
• Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden. hakan.mellstedt@karolinska.se
• Ann. Oncol. 2013 Sep 1; 24 Suppl 5: v23-8.

AbstractBiopharmaceuticals are complex protein molecule drugs produced by living organisms. Biopharmaceuticals as anti-neoplastic monoclonal antibodies are a major breakthrough in oncology. When the patent of innovator biopharmaceuticals expires, copies will be introduced. These copies are after approval by European Medicines Agency (EMA) within EU called biosimilars and have their own regulatory pathways which differ from the chemical generics approval process. The main reason is that identical copies of chemical molecules via chemical syntheses can be produced but copies of innovator biopharmaceuticals will only be similar. An extensive comparability exercise has to be carried out between the reference product and the biosimilar before approval. However, still there might be differences between the innovator anti-neoplastic monoclonal antibody and the biosimilar anti-neoplastic antibody which cannot be detected until extended clinical studies have been carried out. Moreover, all indications for an anti-neoplastic biosimilar antibody may not have been tested for at the time of approval but extrapolated based on the indications of the reference monoclonal antibody. The limited information on biosimilar anti-neoplastic monoclonal antibodies at approval may still be justified taking into account that the aim is to reduce price. However, the risk-benefit ratio for biosimilar anti-neoplastic monoclonal antibodies should be carefully evaluated, considering that anti-neoplastic monoclonal antibody therapy has a curative intent, price reduction so far within EU of biosimilars is modest and that in the end only part of the total costs for cancer health care is related to biopharmaceuticals.

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