skip to content

Environmental Risk Assessments (ERA) for Roche's Active Pharmaceutical Ingredients (APIs)

The publication of environmental risk assessment (ERA) summaries is part of Roche’s engagement on developing a better understanding of issues regarding pharmaceuticals in the environment (PiE). New pharmaceutical substances are investigated for biodegradability and initial ecotoxicity during their development. For registration, a full state-of-the-art environmental risk assessment is developed based on chronic environmental effects and advanced environmental fate data, as required by the pertinent regulations. While not a regulatory requirement, Roche also investigates older pharmaceutical substances, normally at a simpler scale, in order to assess their environmental risks.

For each API, the potential environmental risk is determined as the ratio between the predicted environmental concentration (PEC) of the API in the aquatic environment and the predicted no-effect concentration (PNEC). The PEC is calculated as a worst-case, which assumes no API breakdown (metabolism) by the patient or any removal/degradation of the API during sewage treatment (unless otherwise stated) and uses the total sales volumes for the API in the country with the highest per capita use. For APIs that are also sold by other companies the whole sales volume is taken into account.

A PEC/PNEC ratio of <1 means that the API is unlikely to represent a risk to the aquatic environment. A PEC/PNEC ratio of ≥1 means that there could be a potential risk to the aquatic environment by this API.

To view the environmental risk assessment summary for an API, which includes results of environmental fate and ecotoxicity studies, click on the API name in the table below.

Sustainability Download Centre

Roche ProductActive Pharmaceutical Ingredient (API)Active Pharmaceutical Ingredient (API)
Actemra/RoActemra TocilizumabNo risk*
Alecensa AlectinibRisk is unlikely
Avastin BevacizumabNo risk*
CellceptMycophenolate mofetilPotential risk
ColumviGlofitamabNo risk*
Copegus RibavirinRisk is unlikely
Cotellic CobimetinibRisk is unlikely
Enspryng SatralizumabNo risk*
Erivedge VismodegibRisk is unlikely
Esbriet PirfenidoneRisk is unlikely
Evrysdi RisdiplamRisk is unlikely
Fuzeon EnfuvirtideNo risk*
Gavreto PralsetinibRisk is unlikely
Gazyvaro ObinutuzumabNo risk*
Hemlibra EmicizumabNo risk*
Herceptin TrastuzumabNo risk*
Invirase Saquinavir mesylateRisk is unlikely
Kadcyla Trastuzumab emtansineRisk is unlikely
Lucentis RanibizumabNo risk*
Lunsumio MosunetuzumabNo risk*
MabThera RituximabNo risk*
Madopar BenserazideRisk is unlikely
MadoparLevodopaRisk is unlikely
Mircera C.E.R.A.Risk is unlikely
NeoRecormon Epoetin BetaNo risk*
Ocrevus OcrelizumabNo risk*
PegasysPeginterferon a-2aRisk is unlikely
Perjeta PertuzumabNo risk*
Piasky CrovalimabNo risk*
Polivy Polatuzumab vedotinRisk is unlikely
Pulmozyme Dornase alfaNo risk*
Roaccutane IsotretinoinRisk is unlikely
Rocephin CeftriaxonePotential risk
Rocephin LidocaineRisk is unlikely
Roferon-A Interferon alfa-2aNo risk*
Ronapreve Casirivimab + ImdevimabNo risk*
Rozlytrek EntrectinibRisk is unlikely
Tamiflu OseltamivirRisk is unlikely
Tarceva ErlotinibRisk is unlikely
Tecentriq AtezolizumabNo risk*
Vabysmo FaricimabNo risk*
Valcyte ValganciclovirRisk is unlikely
Xeloda CapecitabineRisk is unlikely
Xofluza Baloxavir marboxilRisk is unlikely
Zelboraf VemurafenibRisk is unlikely

* A PEC/PNEC ratio has not been calculated. According to the European Medicines Agency (EMA), for medicinal products comprised of naturally occurring substances (e.g. vitamins, electrolytes, amino acids, peptides, proteins, nucleotides, carbohydrates and lipids) no specific ERA studies have to be performed. These products are rapidly and extensively degraded and are unlikely to pose a risk to the environment.

Last updated: February 2025

Downloads

Roche Position on Pharmaceuticals in the Environment (PiE)

PDF

Discover more

Positions, policies & downloads

EMA Guideline on Environmental Risk Assessment