Peginterferon alfa-2a

Assessment report

Assessment report for Pegasys (peginterferon alfa-2a) 12 October 2017, EMA/CHMP/54377/2018.

"In addition, PEG-IFN α2a (and IFN α2a) is not mutagenic and not known to be reprotoxic or carcinogenic, also, it is not suspected to have bioaccumulative properties nor endocrine activity. On the other hand, there are experimental data suggesting that the pharmacologically active moiety of Pegasys, IFN α2a, will be rapidly biodegraded. Moreover, based on acute tests, there is no indication for high unexpected ecotoxicity. Therefore, due to its nature, PEG-IFN α2a (and IFN α2a) is unlikely to result in a significant risk to the environment. This conclusion confirms the general finding that monoclonal antibodies and other biologics (protein or peptide) active pharmaceutical substances do not pose a risk to the environment."

Fass environmental information

Fass environmental information for Pegasys from Roche (downloaded 20120-01-29).

Risk

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