Alirocumab

Assessment report

Assessment report for Praluent (alirocumab) 31 January 2019, EMA/152718/2019.

"Alirocumab is a protein derived from biotechnological processes. It is not expected to have an adverse effect on the environment. The Applicant has adequately justified the absence of studies to assess the environmental risk of alirocumab."

Fass environmental information

Fass miljöinformation för Praluent for Sanofi AB (downloaded 2020-01-23).

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.

Even though biomolecules, such as alirokumab (monoclonal antibody), are exempted they should still be regarded as biologically active.