France's Biosimilar Law May Set Trend Inside The EU
Law360, New York (February 18, 2014, 6:26 PM EST) -- Beginning on Jan. 1, 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 "nonsubstitutable." While the details will be defined via the enactment of implementing decrees, under the 2014 Social Security Financing Law ("SSFL"), substitution will be allowed only when initiating a course of treatment, and if the biosimilar belongs to the same group as the prescribed product, known as a "similar biologic group."
Importantly, the definition of what constitutes a "similar biologic group"; the procedure for registration on the biosimilar...
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