EU regulator to review Mylan-Biocon's cancer drug; shares hit new high

Biocon hits 52-week high on European Medicines Agency (EMA) accepting the biosimilar product for review. 

The shares of Biocon was trading at Rs 892.20, surging by Rs 26.60 or 3.07% at 12.17 pm. 

In the early trading session, the stock has also hit a new high of Rs 909.90 as investors cheer for its development. 

The stock opened at Rs 888 higher from its previous closing of Rs 865.60. 

Nearly 78499 shares have been exchanged among investors on BSE index. 

On Thursday, Biocon informed that EMA has accepted for review of Mylan's market authorization application (MAA) for a proposed biosimilar Trastuzumab, which is used to treat certain breast and gastric cancer. 

Biocon and Mylan came into a collaboration agreement to develop and commercialise multiple and high value generic biologic in effect from 2009. 

On acceptance for review, Biocon's CEO and Managing Director, Arun Chandavarkar said, " The regulatory submission for proposed biosimilar Trastuzumab in Europe brings us closer towards enabling affordable access to this critical biological therapy for the treatment of ICR2-positive breast cancer."

This would be the second submission developed by the partnership which has been accepted for review in Europe. 

Mylan President Rajiv Malik commented,"Following our successful commercialization in India and emerging markets, we look forward to our pending launch in Europe. As Europe represents a key market for more affordable versions of these important products, as governments across the region strive to reduce healtcare costs."

Both the companies anticipate that this might become the first MAA for Trastuzumab biosimilar accepted by the EMA for review. 

Earlier last month, Mylan MAA's biosimilar Pegfilgrastim was accepted for review by EMA.