Aflibercept

Detailed information

Assessment report

Assessment report for Eylea (aflibercept) 24 September 2015 EMA/758988/2015.

In line with the Guideline on the environmental risk assessment of medicinal products for human use (CHMP/SWP/4447/00 corr 1), since aflibercept is a protein and unlikely to result in a significant risk to the environment, Eylea is exempted from an environmental risk assessment.

Assessment report for biosimilars

Several aflibercept biosimilars have been approved with corresponding environmental information. The assessment report for Afiveg (EMA/CHMP/203339/2025, 19 June 2025) is presented here.

Aflibercept is a monoclonal antibody (a protein) and is therefore exempt from the requirement for an environmental risk assessment. Aflibercept is not expected to pose a risk to the environment.

Fass environmental information

Fass environmental information for Eylea from Bayer (retrieved on 2026-07-08).

The use of amino acids, proteins and peptides is not considered to have any environmental impact.

"Aflibercept is a recombinant fusion protein consisting of vascular endothelial growth factor (VEGF)-binding portions from the extracellular domains of human VEGF receptors 1 and 2, that are fused to the Fc portion of the human IgG1 immunoglobulin. The protein aflibercept is quickly metabolized in the human body and considered to be readily biodegradable in the environment. Risk or hazard in the environment is not expected.

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.

Generally, even though biomolecules are exempted from environmental risk classification it should be remembered that these molecules may be biologically active. In conclusion, Aflibercept is exempted from the requirement to conduct a risk assessment."

Fass environmental information for Zaltrap (aflibercept) from Sanofi AB (retrieved on 2026-07-08).

The use of amino acids, proteins and peptides is not considered 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, vaccines and herbal medicinal products are exempted because they are unlikely to result in significant risk to the environment. However, even though biomolecules, such as vaccines and hormones, are exempted they should still be regarded as biologically active.

"Even though biomolecules are exempted from environmental risk classification it should be remembered that these molecules may be biologically active."