Biocon Ltd. and Mylan NV announced that Mylan's Marketing Authorisation Application for biosimilar Trastuzumab has been accepted for review by the European Medicines Agency. Mylan and Biocon have co-developed the proposed biosimilar.
This may be the first MAA for a trastuzumab biosimilar to be accepted by the EMA for review, according to a joint press release by both companies on the Bombay Stock Exchange.
Trastuzumab is used to treat certain HER2 (a type of protein) positive breast and gastric cancer, the release adds.
The companies view Europe as a vital market for the product with the government there “striving to reduce healthcare costs” and aim at launching the drug in the market, they said in the release.
The regulatory submission for proposed biosimilar Trastuzumab in Europe takes us a step closer towards enabling affordable access to this critical biological therapy for the treatment of HER2-positive breast cancer.Arun Chandvarkar, CEO and Joint MD, Biocon
In July 2016, Mylan's MAA for Pegfilgrastim biosimilar was accepted for review by the EMA, the release adds.
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