Etanercept

Detailed information

Assessment reports

There are assessment reports for different medicinal products with etanercept ,e.g., 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, Erelzi (etanercept) from Sandoz AB and Enbrel (etanercept) from Pfizer, respectively (downloaded 2023-10-24).

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.

In the information from Sandoz AS and Pfizer

Even though biomolecules are exempted they should still be regarded as biologically active.