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.