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Published on 16 May 2014

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France biosimilar substitution plan progresses

Retail pharmacists in France may become the first in Europe to be able to supply patients with biosimilar versions of the biologic drug indicated on the prescription, if new legislation is ratified in that country.

The move to push the use of cheaper versions of biotech drugs has caused concern in drug companies in Europe’s second-biggest pharmaceutical market behind Germany.

Retail pharmacists in France may become the first in Europe to be able to supply patients with biosimilar versions of the biologic drug indicated on the prescription, if new legislation is ratified in that country.

The move to push the use of cheaper versions of biotech drugs has caused concern in drug companies in Europe’s second-biggest pharmaceutical market behind Germany.

France is the first European county to pursue biologic substitution. Other countries across Europe may follow France’s lead, if the path leads to healthcare savings. IMS Health estimates that France could save as much as 1 billion euros by 2020 from the use of biosimilars.

However, substitution with biosimilars could happen only under certain conditions. For example, it could only be made for a patient who is beginning a course of treatment. Also, it could only be done if the prescriber has not written ‘non-substitutable’ on the form, and the product would have to be included in ‘similar biologic’ groups; these are still to be drawn up by the national healthcare authority Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM).

Furthermore, the new rules would apply only to retail pharmacy, not to hospitals, where more than 40% of French prescriptions for biologic drugs are currently filled.

Nevertheless, industry leaders are angry at not having been consulted during the measure’s development, and they warn that it will make France a less attractive market for the industry.

Philippe Lamoureux, who heads the French research-based industry pharmaceutical industry association Leem, is quoted by Reuters as saying: “we often complain that France and its regulations are incomprehensible and unpredictable, but what happened with biosimilars is a caricature of that.”

Of the world’s ten top-selling prescription drugs, eight are now biotech drugs. ANSM has produced the following list of major products and the years in which their patent protection ends in France:

2014 – Roche’s Herceptin (trastuzumab)
2015 – Roche’s MabThera (rituximab) and AstraZeneca’s Synagis (palivizumab)
2016 – AbbVie’s Humira (adalimumab) and Merck KGaA’s Erbitux (cetuximab)
2017 – Novartis’ Xolair (omalizumab)
2018 – Biogen’s Tysabri (natalizumab) and Roche’s Avastin (bevacizumab)
2019 – Bristol-Myers Squibb’s Orencia (abatacept)



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