Sarilumab

Assessment report

Assessment report for Kevzara (sarlimuab) 21 April 2017 EMA/292840/2017.

"Sarilumab is a monoclonal antibody consisting of natural amino acids, and is therefore not expected to pose a risk to the environment. As such, no ERA was performed.

This is in line with the CHMP Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use (ERA Guideline)."

Fass environmental information

Fass environmental information for Kevzara from Sanofi AB (downloaded 2020-05-05).

Risk

The use of amino acids, proteins and peptides is not expected to have any environmental impact.

Detailed information

According to the European Medicines Agency guideline on environmental risk assessments for pharmaceuticals (EMA/CHMP/SWP/4447/00), vitamins, electrolytes, amino acids, peptides, proteins, carbohydrates, lipids, vaccines and herbal medicinal products are exempted because they are unlikely to result in significant risk to the environment.

However, even though biomolecules are exempted they should still be regarded as biologically active.