Chinese drugmaker scores big in US insulin market

China's Sunshine Lake Pharma has won US Food and Drug Administration approval for its insulin glargine injection, marking the first time a Chinese-developed insulin has obtained the regulator's "interchangeable biosimilar" designation — a milestone that underscores the accelerated entry of Chinese biopharmaceutical companies into high-end global markets.

The label allows pharmacists in the United States to substitute the drug for Lantus — a long-acting insulin originally developed by France's Sanofi — without requiring a new prescription, a regulatory status considered the highest standard for biosimilars and a key advantage in the US market.

Marketed as Langlara, the once-daily administered insulin is approved for adults and children with Type 1 diabetes and for adults with Type 2 diabetes, the Hong Kong-listed company said in a filing to the Hong Kong bourse on Monday.