Paul-Ehrlich-Institut

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Safe­ty, Im­muno­genic­i­ty and In­ter­change­abil­i­ty of Biosim­i­lars

Monoclonal Antibodies and Fusion Proteins with Antibody Moiety in Focus

Biomedical drug bottles and ampoules (Source: Bill Branson/National Cancer Institute)

Biosimilars have been used in the European Union (EU) for 15 years and have helped to reduce costs and improve access to important biological medicines. Despite their now widespread use and proven positive safety record, many prescribers still have doubts about the safety and interchangeability of biosimilars, especially monoclonal antibodies and fusion proteins.

A group of scientists with the participation of the Paul-Ehrlich-Institut has analysed the short- and long-term data on the safety and interchangeability of biosimilars from the field of monoclonal antibodies and fusion proteins and published them in the scientific journal "Drugs". The conclusion: the results indicate that the safety and immunogenicity of biosimilar monoclonal antibodies as well as a fusion protein and their respective reference medicinal products authorised in the European Union are very similar and that these are interchangeable.

The article "Safety, immunogenicity and interchangeability of biosimilars - monoclonal antibodies and fusion proteins with antibody moiety in focus" summarises the main findings of the study.

Updated: 05.01.2022