China’s Sunshine Lake Pharma has secured US FDA approval for its insulin glargine injection, Langlara, becoming the first Chinese-developed insulin to receive the coveted “interchangeable biosimilar” designation. This status permits US pharmacists to substitute it for Sanofi’s Lantus without a new prescription—the highest biosimilar standard.

Approved for Type 1 and Type 2 diabetes, Langlara is now the fourth insulin glargine in the US market and the first from China. The company partnered with US-based Lannett, securing an initial order of at least 18 million units.

With the global insulin glargine market nearing $10billion\text{—}60$10billion—6060 billion in out-licensing deals in Q1 2025, up 73% year-on-year. Several other Chinese insulin makers are now advancing their own FDA submissions.

janus