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EMA and HMA support interchangeability of biosimilars - decision regarding substitution remains with the member states

Author
Zhuleku Eda
Eda Zhuleku

Counsel

Munich

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Image of Florian Preinfalk
Florian Preinfalk

Associate

Munich

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21 September 2022

On 19 September 2022, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have published a joint statement confirming that biosimilars authorized in the EU are interchangeable. The EMA defines interchangeability as the possibility to use a medicinal product instead of another one without any changes in its clinical effect. 

According to the statement, the EMA and HMA express their view that (i) a biosimilar can be used instead of its reference product (or vice versa) or (ii) one biosimilar can be replaced with another biosimilar of the same reference product. 

This marks the first official recommendation of the EMA on this subject, aiming to address uncertainties among prescribers and support patient access to biosimilars. The significance of this statement lies in particular in the support from the HMA given the EMA´s general acceptance of the principle of interchangeability. 

The statement is based on experience with over 80 biosimilars, which have been authorized in the EU since 2006 and the fact that these biosimilars have shown similar levels of safety, efficacy and immunogenicity in comparison with their reference products according to the EMA. 

Even though the recommendation of EMA and HMA might strengthen the position of biosimilars in the EU, the statement will not have any immediate legal implications. It is within the competence of the Member States to take decisions on the substitution at pharmacy level (without consultation with the prescriber). To date far fewer European countries permit substitution of biosimilars than small-molecule generics, whereby there is a trend towards increased substitution of biologics. In Germany for example, the substitution at pharmacy level is not possible at the moment. However, the Federal Joint Committee (Gemeinsamer Bundesausschuss) is entitled to set up rules enabling the substitution of biosimilars and has already published a draft guideline, which is expected to come into force in August 2023. 

It remains to be seen whether the statement of the EMA and HMA will further affect the national legislations on biosimilars in the European countries. We will keep you informed about future developments.

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