Frequently asked questions about biological and biosimilar medicinal products

29 January 2016

Information for patients

What is a biological medicinal product?

A biological medicinal product is derived from a biological source, such as mammal cells, yeast or bacteria. Biological medicinal products have a more complex molecular structure than a non-biological chemically produced medicinal product.

What is a biosimilar medicinal product?

A biosimilar medicinal product is a new version of an existing biological medicinal product, whose patent has expired, which means that the product has been authorised for at least 10 years. 

Why are biosimilar medicinal products similar and not identical with the reference medicinal product?

Since biosimilar medicinal products are made from biological material, there may be minor differences in the molecule in relation to the original biological medicinal product (variability between batches is also seen, which is quite normal), known as the reference medicinal product. However, these differences must not have an impact on the efficacy and adverse reactions compared with the reference medicinal product.

Do biosimilar medicinal products have a lower quality, efficacy and safety profile than the reference medicinal product.

No. To be authorised as a medicinal product, it must be documented that a biosimilar medicinal product has the same quality, efficacy and safety profile as the reference medicinal product.

Is the biosimilar medicinal product consumed in the same way as the reference medicinal product?

A biosimilar medicinal product administered by infusion is used in the same way as the reference medicinal product. A biosimilar medicinal product administered by injection under the skin may be placed in different syringe or pen.

How will I know whether I get a biosimilar medicinal product or a reference medicinal product?

Your doctor can inform you if you get a biosimilar medicinal product. Any other information, including the package leaflet, is usually identical with that of the reference medicinal product.

Is there a greater risk that patients create antibodies against biosimilar medicinal products compared with the reference medicinal product?

No. The production of antibodies can occur when taking biological medicinal products as well as biological medicinal products. Biosimilar medicinal products are not associated with an increased risk of antibody production.

What happens when you start taking a biosimilar medicinal product?

Since the active substance in biosimilar medicinal products only has minor differences in the molecule compared with the reference medicinal product, there is no impact on efficacy or adverse reactions and the medicinal products work in the same way. If you start taking a biosimilar medicinal product, without having taken the reference medicinal product, the effect will occur at the same time as can be expected for the reference medicinal product.

Would it be problematic to switch to a biosimilar medicinal product?

No. The biosimilar medicinal product can only be authorised if it has the same efficacy profile as the reference medicinal product, and consequently you will not experience any changes in your treatment if you switch to a biosimilar medicinal product.

What can I do if the biosimilar medicinal product does not work?

If you experience that the effect of the biosimilar medicinal product wears off or stops completely, your disease may have increased in severity or the active substance may no longer be an effective treatment of your disease. In that case, the reference medicinal product would not be effective either. Your doctor can help you work out the best treatment options.

What are the likely adverse reactions from biosimilar medicinal products?

You can expect the same adverse reactions as those associated with the reference medicinal product.

What does the “black triangle” on the package mean?

The black triangle is added to all biosimilar medicinal products because they are biological medicines. The triangle means that the medicinal product is subject to additional monitoring. The black triangle does not indicate a particular concern for biosimilar medicines, but that additional monitoring applies to biological medicinal products in general.

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