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biosimilar

A ‘biosimilar’ medicinal product is a medicinal product that is equivalent to a biological medicinal product that has previously already obtained marketing authorisation (the ‘biological reference medicinal product’). The active substance in a ‘biosimilar’ medicinal product is equivalent to the active substance of the biological reference medicinal product. Biosimilar medicinal products and biological reference medicinal products are generally used in equal doses when treating the same condition. The name, form and packaging of a biosimilar product may deviate from that of the reference product.

As biosimilar products are similar – but not identical – to the innovator product, every biosimilar medicinal product is assessed separately. Just as with all other medicinal products, you must acquire a marketing  authorisation before the product can be marketed. Again, like all other medicinal products, the safety of the biosimilar will be continuously monitored after marketing authorisation is granted.

If a patient switches from one biological medicinal product to another this must be carefully monitored by the treating physician. This is true both for innovator products and for the  interchangeable medicinal products.

 

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