Pharmacie Kennedy Mulhouse

Biosimilar medicine: why is it not a generic?

A biosimilar is compared with a reference biological medicine. Ask about that comparison and, if needed, the device used for the medicine already prescribed.

Editorial illustration of a health discussion; it does not depict the pharmacy’s actual premises.
Editorial illustration — Kennedy Pharmacy Mulhouse

General information, not an individual diagnosis. Ask a healthcare professional if you are unsure about your situation.

The word ‘biosimilar’ may come up when a doctor or pharmacist discusses a medicine already prescribed. It describes a biological medicine comparable to a reference product; it is a different category from generic medicines.

These medicines are made using living cells or organisms. ‘Biological’ therefore does not mean organic farming. Manufacturing variability explains why a biosimilar and its reference are similar without being completely identical.

To receive authorisation, a biosimilar must demonstrate high similarity to its reference and no clinically significant difference in quality, safety or efficacy. The comparison concerns these criteria, rather than just a name or a box.

Ask the professional to name the reference biological medicine and the product being dispensed. Have them explain why the term biosimilar appears in your care, rather than drawing conclusions from the packaging’s appearance.

If an administration device is new to you, ask for a demonstration specific to the product dispensed. Ameli describes help from the pharmacist when learning a new device is necessary during substitution. Keep the instructions for that product.

The term biosimilar does not enable you to decide on your own to replace one treatment with another. Ask your doctor or pharmacist what is planned for your prescription. Keep the product’s name and your questions for your next discussion.

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