Etanercept

Assessment reports

There are several medicinal products with etanercept approved and the latest assessment report is for Nepexto (etarnercept) March 26, 2020, EMA / 212524/2020.

"The applicant provided a justification for not submitting any environmental risk assessment studies based on the fact that etanercept is a protein and therefore unlikely to pose a significant risk to the environment which is in accordance with the CHMP Guideline on the environmental risk assessment of medicinal products for human use (EMEA/CHMP/SWP/4447/00 corr 2)."

Fass environmental information

Fass environmental information for Benepali (etanercept) from Biogen Sweden and Erelzi (etanercept) from Sandoz AB, respectively.

Risk

The use of amino acids, proteins and peptides is not considered 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.

Further information is available from Sandoz AB, including the following: "Etanercept is a fusion protein consisting of the Fc-domain of IgG1 antibodies and a binding domain of the human tumor necrosis factor receptor 2. It can be expected that any medicinal absorbed etanercept is completely metabolized and adsorbed in the body. Any medicinal product that reaches water streams via eventual spills during application or after disposal of unused drug is expected to be very rapidly degraded and mineralized to CO₂ by microbial activity."