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Stakeholders Surprised As French Biosimilar Substitution Changes Tack

France’s Health Ministry And ANSM Agency Deviate From Approach Agreed In Consultation

 
• By Dave Wallace

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.

Change course new direction red paper aeroplane changing tack
France has seen an unexpected change in direction on biosimilar substitution • Source: medrooky / Alamy Stock Photo

While France’s gradual progress over the years towards implementing pharmacy-level substitution for biosimilars has largely been welcomed by French off-patent industry stakeholders, the latest move by the country’s authorities has left some scratching their heads.

An official list of biosimilars eligible for substitution – published in France’s official journal in mid-April – has seen the French health ministry and the country’s medicines agency, ANSM, deviate from an approach that had previously been agreed through a stakeholder consultation, with the authorities without warning

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