 "European Medical Agency to review Biocon-Mylan's anti cancer biosimilar")
Biocon today announced that European Medicine Agency (EMA) will review the marketing authorisation application for anti cancer biosimilar Trastuzumab, which is being co-developed with drug maker Mylan. The companies believe that theirs could be the application taken up for review by EMA.
In a statement Arun Chandavarkar, CEO and joint managing director of Biocon said the regulatory submission for the proposed biosimilar Trastuzumab in Europes takes it a step closer towards enabling affordable access to this critical biologic therapy for breast cancer.
This is the partnership's second biosimilar submission that is accepted for review in Europe. Last month Mylan's application for biosimilar Pelfilgrastim was accepted for review in Europe, Biocon said in a statement today.
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