France to allow biosimilars substitution

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France to allow biosimilars substitution

Home/Policies & Legislation | Posted 21/02/2014 0 Post your comment

Pharmacists in France will now be allowed to substitute a biosimilar for the prescribed (reference) biological under certain conditions, including only when initiating a course of treatment and that the prescribing physician has not marked the prescription as ‘non-substitutable’.

Legislation allowing substitution of biosimilars has been introduced as part of a new law concerning the social security budget (Article 47 of the Law of 23 December 2013), which came into effect on 1 January 2014. Provisions in the law that allow the substitution of originators by generics have been adapted to extend to biosimilars.

Substitution of biosimilars is allowed only when initiating a course of treatment, if the biosimilar belongs to the same group as the prescribed product, known as a ‘similar biologic group’, and if the prescribing physician has not explicitly prohibited substitution of the prescribed biological by indicating ‘non substituable’ (non-substitutable) in handwritten characters on the prescription. The ‘similar biologic groups’ will be drawn up by the French healthcare authority ANSM (Agence nationale de sécurité du médicament et des produits de santé).

When prescribing a biological, physicians are required to specify on the prescription whether this is the first time the biological is prescribed. If it is, the pharmacist can then fill the prescription with the least costly product within the group of biological products, typically, the biosimilar.

If the pharmacist substitutes a biosimilar for the prescribed biological, they must write both the name of the dispensed product on the prescription and inform the prescribing physician. If the treatment is continued and the prescription is renewed, the same (substituted) medicine should be dispensed.

The details for substitution of biosimilars, including: (1) the criteria for inclusion in a ‘similar biologic group’ by the ANSM; (2) the procedure for registration on the biosimilar register (entitled ‘list of reference of similar biologic groups’) and the content of that list; and (3) the precise conditions for biosimilar substitution by a pharmacist; will be defined via the enactment of implementing decrees by the Administrative Supreme Court, under the 2014 Social Security Financing Law. This means that in practice biosimilars substitution will only occur after these decrees have been adopted.

France is the first European country to explicitly permit biosimilar substitution. In the European Union (EU), decisions on pharmacy substitution of biosimilas are made at the Member State level. To date, no other EU country has explicitly authorized the substitution of biologicals from different manufacturers and a number of EU Member States have gone as far as banning this practice [1].

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Reference

1. GaBI Online - Generics and Biosimilars Initiative. Possibility of substitution of biosimilars in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Feb 21]. Available from: www.gabionline.net/Reports/Possibility-of-substitution-of-biosimilars-in-Europe

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