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Biosimilar Substitution in France: No Way Back?

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Rudoni Alexandre
Alexandre Rudoni

Partner

Paris

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Benard Laetitia
Laëtitia Bénard

Partner

Paris

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08 January 2014

Beginning on 1 January 2014, French pharmacists are now legally permitted to substitute a biosimilar for the prescribed (reference) biological medicine as long as the prescribing physician has not marked the prescription as “non-substitutable”.  According to the new law, substitution is allowed only when initiating a course of treatment, and if the biosimilar belongs to the same grouping as the prescribed product, known as a “similar biologic group.”  These groupings will be drawn up by the French health care authority ANSM. 

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