Risk. Use of amino acids, proteins and peptides is not considered to cause any environmental impact.
This summary information comes from Fass and corresponding information can be found in assessment reports.
Assessment report for Repatha (evolocumab) 21 May 2015, EMA/CHMP/222019/2015.
"No ERA have been done, which is agreed seen the nature of the product. Evolocumab is a protein composed of normal amino acids and readily biodegradable. Therefore it does not pose a risk for the environment."
Assessment report for Repatha, 22 February 2018, EMA/233126/2018.
Fass environmental information
Fass environmental information for Repatha from Amgen (downloaded 2023-09-25).
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.
Author: Health and Medical Care Administration, Region Stockholm