New legislation in France would allow retail pharmacists there to become the first in Europe to be able to supply patients with biosimilar versions of the biologic drug indicated on the prescription.
The new rule, contained within Article 47 of this year’s social security budget legislation which was passed last December 23, would permit substitution under certain conditions. For example, it could only be made for a patient who is beginning a course of treatment – substitution could not be made part-way through a course. 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 ANSM, with recommendations expected in June.
Moreover, while the new rules took effect on January 1, they cannot go into operation until the relevant decrees have been adopted by France’s Administrative Supreme Court under the terms of the 2014 Social Security Financing Law. And they 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 10 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, or had ended, in France:
- 2011 - Pfizer/Amgen’s Enbrel (etancercept);
- 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); and
- 2019 – Bristol-Myers Squibb’s Orencia (abatacept).
IMS Health estimates that France could save as much as 1 billion euros by 2020 from the use of biosimilars.