Biocon surged 14% to Rs 510, also its all-time high on the BSE in early morning trade, after the company said it has secured a regulatory approval to market a biosimilar for anti-cancer drug Herceptin in the US. Mylan and Biocon announced that US Food and Drug Administration (FDA) have approved Mylan’s Ogivri, a biosimilar to Herceptin, co-developed with Biocon. “Ogivri has been approved for all indications of the reference product, Herceptin, including for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer. Ogivri is the first FDA-approved biosimilar to Herceptin and the first biosimilar from Mylan and Biocon’s joint portfolio approved in the US,” Biocon said in a statement. In the US an estimated 250,000 new cases of female breast cancer and 28,000 new cases of stomach cancer are expected to be diagnosed in 2017 alone.
Approximately 20% to 25% of primary breast cancers are HER2-positive. Herceptin had US sales of more than $2 billion for the 12 months ending September 30, 2017, according to IQVIA. At 09:48 AM; the stock was up 10% at Rs 490 on the BSE, as compared to 0.22% rise in the S&P BSE Sensex. The trading volumes on the counter nearly doubled with a combined 9.55 million shares changed hands on the NSE and BSE so far.