Hazard - P - B - T - Risk Exempt
There are assessment reports for different medicinal products with adalimumab. The latest information is for Kromeya (adalimumab), 31 January 2019, EMA/214726/2019.
"According to the CHMP Guideline on the Environmental Risk Assessment (ERA) of Medicinal Products for Human Use (EMEA/CHMP/SWP/4447/00 corr 2) for products containing vitamins, electrolytes, amino acids, peptides, proteins, carbohydrates and lipids as active pharmaceutical ingredient(s), an ERA should be provided. This ERA may consist of a justification for not submitting specific ERA studies. According to Directive 2001/83/EC, applicants are required to submit an ERA also for applications under Art 10(4) similar biological applications. The active substance is a protein composed of natural amino acids, the use of which will not alter the concentration or distribution of the substance in the environment. Therefore, adalimumab is not expected to pose a risk to the environment."
Fass environmental information for Humira (adalimumab) from AbbVie (downloaded 2019-09-03).
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