Anakinra

Detailed information

Assessment report Kineret 2018

Assessment report for Kineret (anakinra) 22 February 2018 EMA/CHMP/169769/2018.

"The drug substance anakinra is a recombinant protein (Interleukin-1 receptor antagonist) produced in E. coli bacteria containing an expression plasmid in which a synthetic gene coding for human IL-1Ra has been inserted.According to the Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use (EMEA 2006), proteins are exempted from environmental risk assessment because they are unlikely to result in significant risk to the environment. The product does not contain any other components that would require an environmental risk assessment under the European Medicines Agency guidelines."

Assessment report Kineret 2021

Assessment report for Kineret, 16 December 2021, EMA/772497/2021.

Anakinra is a recombinant protein that closely resembles the naturally occurring human interleukin-1 receptor antagonist. Therefore, the MAH justified the absence of environmental risk assessment (ERA) studies in accordance with the EMA guideline on the environmental risk assessment of medicinal products for human use (EMEA/CHMP/SWP/4447/00 Rev1). The justification was considered acceptable.

Fass environmental information

Fass environmental information for Kineret from Sobi (retrieved on 2019-07-10).

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 proteins, vaccines and herbal medicinal products are exempted because they are unlikely to result in significant risk to the environment.