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.
There are assessment reports for different medicinal products with adalimumab, e.g., 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
Fass environmental information for Humira (adalimumab) from AbbVie (downloaded 2023-10-24) and Amsparity (adalimumab) from Pfizer (downloaded 2023-10-24).
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.
- European Medicines Agency. European public assessment reports (EPAR). Kromeya (adalimumab), 31 January 2019, EMA/214726/2019.
- European Medicines Agency, EMA: Committee for Medicinal Products for Human Use (CHMP). Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use. 1 June 2006.
- Fass för vårdpersonal.
Author: Health and Medical Care Administration, Region Stockholm