Biocon shares jumped 5 per cent to their 52-week high on Friday after the drugmaker announced that the European regulator has accepted for review a breast cancer biosimilar jointly developed with Mylan. Biocon and American-Dutch Mylan are exclusive partners on a broad portfolio of biosimilars and insulin analogs.
“The European Medicines Agency (EMA) has accepted for review Mylan’s Marketing Authorization Application for a proposed biosimilar Trastuzumab, which is used to treat certain HER2-positive breast and gastric cancers. This is the second biosimilar submission developed by the partnership that has been accepted for review in Europe,” Biocon said in a statement.
According to Biocon, this may be the first application for a Trastuzumab biosimilar accepted by European regulator for review. If the drug gets approval, Biocon will become the first Indian biotech company to crack a highly regulated market, analysts say.
“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,” said Arun Chandavarkar, chief executive and joint managing director of Biocon.
Sanjeev Bhasin of IIFL said it’s a positive development for Biocon, which has been a standout performer on account of traction in its insulin and biosimilars business.
“It is a big positive. Buy Biocon on dips as the stock can rise to Rs 1,100,” Mr Bhasin added.
As of 09.40 a.m., Biocon shares traded 4.7 per cent higher at Rs 905.85, outperforming the broader Nifty that traded 0.3 per cent higher.