Mylan co-developed the product candidate with Indian biopharmaceutical company Biocon.
Trastuzumab is one of the six biologic products co-developed by both the firms for the worldwide marketplace.
Mylan has exclusive commercialization rights for Trastuzumab in the US, Canada, Japan, Australia, New Zealand, the European Union and European Free Trade Association countries.
Biocon has co-exclusive rights with Mylan in the rest of the world.
Biocon CEO and joint managing director Arun Chandavarkar said: "The regulatory submission for proposed biosimilar Trastuzumab in Europe takes us a step closer towards enabling affordable access to this critical biologic therapy for the treatment of HER2-positive breast cancer.”
The filing includes analytical, functional and pre-clinical data, as well as results from the pharmacokinetics (PK) and confirmatory efficacy/safety global clinical trials for Trastuzumab.
The PK study showed measured bioequivalence of Trastuzumab biosimilar relative to that of the reference drug.
The second study, dubbed the Heritage, assessed the efficacy, safety and immunogenicity of Trastuzumab in comparison to branded Trastuzumab.
Roche’s subsidiary Genentech sells Trastuzumab, under the brandname Herceptin.