 "Biocon hits fresh record high as EMA accepts biosimilar for review")
Shares of Biocon hit a fresh record high of Rs 910, up 5% on the BSE in early morning trade, after the company announced Mylan’s application to market biosimilar Trastuzumab has been accepted by the European Medicines Agency (EMA) for review. The biosimilar Trastuzumab is used to treat certain breast and gastric cancers.
“Mylan and Biocon, which have co-developed this popular biosimilar, anticipate that this may be the first Marketing Authorization Application (MAA) for a biosimilar Trastuzumab accepted by the EMA for review,” Mylan and Biocon said in a joint press release.
“This is the second biosimilar submission developed by the partnership that has been accepted for review in Europe,” it added.
The filing includes analytical, functional and pre-clinical data and results from the pharmacokinetics and confirmatory safety global clinical trials for Trastuzumab, the company said.
At 09:29 am, the stock was up 4.7% at Rs 906 on the BSE, as compared to 0.29% rise in the S&P BSE Sensex. The counter has seen huge trading volumes with a combined 1.26 million equity shares changing hands in first 15 minutes of trade on the NSE and BSE.
“Mylan and Biocon, which have co-developed this popular biosimilar, anticipate that this may be the first Marketing Authorization Application (MAA) for a biosimilar Trastuzumab accepted by the EMA for review,” Mylan and Biocon said in a joint press release.
“This is the second biosimilar submission developed by the partnership that has been accepted for review in Europe,” it added.
The filing includes analytical, functional and pre-clinical data and results from the pharmacokinetics and confirmatory safety global clinical trials for Trastuzumab, the company said.
At 09:29 am, the stock was up 4.7% at Rs 906 on the BSE, as compared to 0.29% rise in the S&P BSE Sensex. The counter has seen huge trading volumes with a combined 1.26 million equity shares changing hands in first 15 minutes of trade on the NSE and BSE.