Stelara becomes substitutable in France

Stelara, a biological medicine in the ustékinumab biosimilar group, is now substitutable in pharmacies in France since April 14, 2026, according to reports. This means pharmacists can replace it with another similar medication from the same group unless the prescribing doctor explicitly opposes the substitution by adding a justified note on the prescription.

Conditions for dispensing biosimilars

Pharmacists must adhere to specific conditions when dispensing a biosimilar from this group. They must respect the therapeutic indication of the medication, as it varies among the biosimilars of Stelara based on their marketing authorization.

Pharmacist responsibilities during substitution

Pharmacists must provide the administration device specified by the prescriber, such as a syringe or pen. They must also inform patients about the substitution and provide necessary information, including storage rules and training on the new device using models provided by the laboratories.

Continuity and documentation requirements

Pharmacists must ensure the continuation of the same medication during subsequent dispensations, inform the prescriber of the substitution, note the actual medication dispensed on the prescription, and record the name of the substituted specialty and its batch number for traceability.

Special dispensation rules for Stelara

Stelara is classified as an expensive medicine under the French system, which requires pharmacists to note on the prescription either "Refusal of dispensation" or "Secure dispensation," then scan and send the document to the Health Insurance. If there is doubt about the authenticity of the prescription, the pharmacist may dispense the minimal packaging and note "Temporary dispensation."

Additional safety requirements

Women of childbearing age must use effective contraception during treatment and for 15 weeks after stopping the treatment. The article "Biological Medicines Substitutable by Pharmacists Expand" provides further details on the expanding list of substitutable biological medicines. The article "Medication with Particular Dispensation: Focus on Stelara" was first published on Le Moniteur des pharmacies.