Alemtuzumab

Assessment report

Assessment report for Lemtrada (alemtuzumab) 27 June 2013 EMA/563018/2013.

"Environmental risk assessment of alemtuzumab was not performed. [...] The lack of an environmental risk assessment (ERA) was deemed acceptable in accordance with the current guidance. Alemtuzumab is a monoclonal antibody and therefore, it is exempt from the ERA requirements, as proteins are considered not to pose significant risks to the environment."

Fass environmental information

Fass environmental information for Lemtrada från Sanofi AB (downloaded 2020-02-21).

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 proteins, vaccines and herbal medicinal products are exempted because they are unlikely to result in significant risk to the environment.

However, even though biomolecules, e.g. alemtuzumab that is a protein (antibody), are exempted they should still be regarded as biologically active.