Mylan N.V. (NASDAQ:MYL) and partner Biocon Ltd. (NSE:BIOCON; BSE:BIOCON) said they recently received a complete response letter from FDA for their follow-on of diabetes drug Lantus insulin glargine from Sanofi (Euronext:SAN; NYSE:SNY).
The partners said they expected the decision and have already started the required activities the companies agreed on with FDA, which include providing the agency with additional clinical data to allow the partners to change the compound's manufacturing site to Malaysia from Bangalore.
The application had been submitted under section 505(b)(2) of the Food, Drug and Cosmetic Act, which allows sponsors to reference data on safety and efficacy from scientific literature or from previously approved products.
In March, the European Commission and Australia's Therapeutic Goods Administration each approved the product, which Mylan markets as Semglee.
Biocon markets it in Japan as Basalog.
On Monday, FDA approved the partners’ Fulphila pegfilgrastim-jmdb, which is a biosimilar of neutropenia drug Neulasta from Amgen Inc. (NASDAQ:AMGN) (see BioCentury Extra, June 4).
Lantus is a long-acting human insulin analog.