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Biocon and Mylan have submitted the biosimilar Trastuzumab to the European Medicines Agency (EMA) for approval.
Trastuzumab is used to treat certain kinds of breast and gastric cancers.
If the approval is given, Mylan and Biocon, which have co-developed this proposed biosimilar, expect this to be the first marketing authorisation application for a Trastuzumab biosimilar accepted by the EMA.
Rajiv Malik, President, Mylan, said that Europe represents a key market for more affordable versions of these important products, as governments across the region strive to reduce healthcare costs.
Arun Chandavarkar, CEO and Joint Managing Director, Biocon, 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.”
This is the second biosimilar submission developed by the partnership, which has been accepted for review in Europe.
Last month, Mylan’s MAA for the proposed biosimilar Pegfilgrastim was accepted for review by EMA.
This filing includes analytical, functional and pre-clinical data, as well as results from the pharmacokinetics (PK) and confirmatory efficacy or safety of global clinical trials for Trastuzumab.
The generic version of Trastuzumab is comparable to Roche Holding AG's branded Trastuzumab, according to a study.
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