French Body Favors Pharmacy Substitution For Biosimilars
But Move Is Not Supported By Wider European Off-Patent Industry
French off-patent association Gemme has made a bold show of support for pharmacy-level biosimilar substitution in a position statement published by the industry body. However, the proposals run against the views of broader European industry association Medicines for Europe and come against the backdrop of recently-adopted French legislation that ensures doctors will be involved in biologic substitution.
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Stakeholders in Europe have been hesitant to allow interchangeable substitution of biological products, prompting the European Medicines Agency to clarify its stance on the issue.
French off-patent industry association Gemme has welcomed the entry into force of biosimilar substitution – but has protested against recent and ongoing price cuts for small-molecule generics in the context of unprecedented cost pressures.
The latest step towards biosimilar substitution taken by the French authorities has left stakeholders baffled by an unexplained shift in approach, including a change to the specific biologic molecules that have been selected as eligible for substitution.