EU Commission approves Semglee developed by Biocon and Mylan
Semglee is a biosimilar to insulin glargine and is co-developed by the two companies. The product will be offered in a 100 units/mL 3 mL prefilled disposable pen.
Insulin glargine is a basal insulin analogue with long-acting effect. It is administered once daily to control the blood sugar level in diabetic patients. Insulin glargine was originally developed by Sanofi and is sold under the brand name Lantus.
Biocon and Mylan have an exclusive partnership to co-developed a portfolio of biosimilars including insulin analogs for the international market. Semglee received a positive feedback from European Medicines Agency's the Committee for Medicinal Products for Human Use (CHMP) following which the European Commission have given market authorization for the drug in Europe. While the Australian regulatory Therapeutic Goods Administration (TGA) has approved its use in Australia.
Meanwhile, at 14:03 hours, stock of Biocon was trading at Rs. 600 per share, down by 0.40 per cent, when the benchmark index BSE Sensex was at 33,034.70, down by 137.80 points or 0.42 per cent.