Risk. Use of amino acids, proteins and peptides is not considered to cause any environmental impact, but see further information in the Fass text.
This summary information comes from Fass and corresponding information can be found in assessment reports.
Assessment report for Praluent 25 juni 2020
Assessment report for Praluent (alirocumab) 25 June 2020, EMA/379767/2020.
"Alirocumab is a monoclonal antibody derived from biotechnological processes, the use of which will not alter the concentration or distribution of the substance in the environment. Therefore, it is not expected to have an adverse effect on the environment."
Assessment report for Praluent 31 January 2019
Assessment report for Praluent 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).
The use of amino acids, proteins and peptides is not expected to have any environmental impact.
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.
Author: Health and Medical Care Administration, Region Stockholm