The European Commission approved Semglee, a biosimilar version of Sanofi's blockbuster drug Lantus.
Mylan NV and India-based biotechnology company Biocon Ltd. co-developed the medicine, intended for diabetes patients. The biosimilar was also approved in Australia.
The companies are also seeking approval for Semglee in U.S. and Canada.
Sanofi's Lantus generated €4.62 billion in global sales in 2017, the most in its diabetes franchise, which had combined sales of €6.40 billion the same year.