Mylan N.V. and Biocon Ltd. recently announced that Mylan’s Marketing Authorization Application (MAA) for Trastuzumab has been accepted by the European Medicines Agency (EMA) for review.
Trastuzumab is a proposed biosimilar designed for the treatment of HER2-positive breast cancer as well as gastric cancer.
"The acceptance of our regulatory submission of our proposed biosimilar Trastuzumab in Europe is another example of the strong progress we continue to make across our broad biosimilars portfolio,” Rajiv Malik, President of Mylan, said. “Following our successful commercialization in India and emerging markets, we look forward to our pending launch in Europe. Europe represents a key market for more affordable versions of these important products, as governments across the region strive to reduce health care costs. We look forward to continuing to work to bring this product to patients upon approval."
Trastuzumab is the second biosimilar joint-developed by the two companies.
"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,” Biocon CEO and Joint Managing Director Arun Chandavarkar said. “We remain committed to bring a diversified portfolio of high-quality, life-enhancing biosimilars to patients globally."
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