Use of biosimilars in oncology in France

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Use of biosimilars in oncology in France

Biosimilares/Investigación | Posted 02/09/2016 0 Post your comment

Biosimilar drugs are biological drugs clinically similar to their reference products. They correspond to a generic drug approach applied to biological agents. The goal of biosimilars is to open the market and to provide significantly less costly biological agents. The approval of biosimilars is abbreviated when compared to that of the reference biologicals, but includes clinical trials (distinguishing them from generics). In oncology, the currently available biosimilars filgrastim and epoetin alfa are used in supportive care. Author Dominique Leveque from the Hôpital Hautepierre, Strasbourg, France discusses the situation regarding the use of biosimilars in France [1].

In France, some oncologists are reluctant to the use of biosimilars (filgrastim) in extrapolated indications for the mobilization of haematopoietic progenitor cells. Lack of acceptance of biosimilars is often relative to a lack of education (‘emotion-based medicine’). In oncology, it seems paradoxical to be less confident in products with an official labelling than in anticancer agents used off-label (a frequent practice). Since biosimilars have been approved by the European Medicines Agency (EMA) in terms of efficacy, safety and quality, there is no rational reason to have doubts about their clinical value. Healthcare professionals have to be fully informed on the approval process and the huge progress that has been achieved in the production and analytical characterization of biologicals.

Beyond that, pricing is the key issue for wider acceptance of biosimilars. In France, the price of drugs is negotiable in the hospital setting. Filgrastim is currently discounted by more than 90% and this has led to the widespread and almost exclusive use of biosimilars in French hospitals (excluding use for leucapheresis). By contrast in the outpatient setting (community pharmacies), the price of reimbursed drugs is fixed and concerning biosimilars (filgrastim, epoetin alfa), the discount is weak (10–15% of the reference product’s price); it is far less than that obtained in hospitals or with generics (60% discount compared to the reference product).

In the future, the monoclonal antibodies rituximab (haematology) and trastuzumab (breast and gastric cancer) that are administrated in the hospital setting will be launched. This could result in major cost savings for French hospitals. However, the use of biosimilars could be impeded by the fact that some manufacturers have countered their arrival with alternative formulations of their reference products, e.g. subcutaneously administered forms, or new agents.

Enhanced communication with oncologists and negotiation through competition with reference products in the hospital setting will improve their acceptance. In an environment of crisis and restrictive healthcare budgets, obtaining and using more cost-effective biosimilars will also help to cover new and very expensive anticancer agents (immunotherapies and drugs for myeloma).

Conflict of interest
The author of the research paper [1] did not provide any conflict of interest statement.

Abstracted by Dominique Leveque from the Hôpital Hautepierre, Strasbourg, France.

Reference
1. Levêque D. [Biosimilar drugs in oncology]. [Article in French]. Bull Cancer. 2016 Mar;103(3):294-8. doi:10.1016/j.bulcan.2015.12.004. Epub 2016 Jan 29

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