Hazard - P - B - T - Risk Exempt
"No additional ERA was provided as the MAH justified that no appreciable risk for the environment emerges from the use of Xolair. The CHMP accepted the justification."
"The MAH (Marketing Authorisation Holder, red. anm.) has submitted an updated summary of environmental risk assessment (ERA) aspects. No complete ERA, in accordance with Directive 2001/83/EC and Guideline CHMP/SWP/4447/00, has been conducted. The rationale for this is that it can be expected that any omalizumab adsorbed into the bloodstream after subcutaneous injection is largely catabolized. As other naturally occurring IgGs, proteins or peptides, any omalizumab that reaches water streams via eventual spills during application or after disposal of unused drug is expected to be very rapidly consumed by microbes e.g. as energy/carbon source or incorporated by them. Accordingly, the MAH does not predict any adverse environmental effects from omalizumab."
Fass environmental information for Xolair from Novartis (downloaded 2019-08-21).
The use of amino acids, proteins and peptides is not expected to have any environmental impact.
"Use of amino acids/peptides/proteins has been considered to result in insignificant environmental impact. In the case of products containing vitamins, electrolytes, amino acids, peptides, proteins, carbohydrates and lipids as active pharmaceutical ingredient(s), an ERA should be provided. This ERA may consist of a justification for not submitting ERA studies, e.g. due to their nature they are unlikely to result in a significant risk to the environment. The same applies to vaccines and herbal medicinal products (European Medicines Agency guideline on Doc. Ref. EMEA/CHMP/SWP/4447/00 corr 2). It can be expected that any medicinal absorbed monoclonal antibody 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."
Author: Health and Medical Care Administration, Region Stockholm