Chinese insulin breaks into US market as new drug secures FDA approval

Chinese pharmaceutical company Sunshine Lake Pharma has become the first Chinese firm to win US Food and Drug Administration (FDA) approval for a long-acting insulin product, marking a milestone for the country's biopharmaceutical industry.

The company announced on Monday that their insulin glargine injection, sold under the brand name Langlara, received FDA approval. It is only the fourth insulin glargine product to enter the US market, joining offerings from global giants Novo Nordisk, Sanofi and Eli Lilly.

The approval includes an interchangeable designation – the highest standard for biosimilar drugs – meaning pharmacists can substitute it for the branded version without requiring a new prescription from doctors. The company has already secured an initial order of at least 18 million vials from its US partner Lannett, with supply scheduled over 18 months.

The US is the world's largest insulin market, with annual spending exceeding $400 billion and accounting for nearly 80% of global sales. The market has long been dominated by the three multinational pharmaceutical companies.

Sunshine Lake Pharma began developing its insulin portfolio in 2008 and has invested more than 2 billion yuan ($280 million) in the business. The company currently produces over 100 million vials annually at its manufacturing facility, with capacity set to expand to 180 million vials.

The company adopted a strategy of entering emerging markets before targeting the US and Europe. Its insulin products have already been approved in the United Arab Emirates, Algeria and Mali, with operations spanning the Middle East, Latin America and Southeast Asia.

The FDA approval is expected to accelerate market entry in other countries, including Brazil, Argentina, Indonesia and Türkiye. The company is also seeking US approval for another insulin product, with a decision expected in 2028.

Industry analysts said the approval comes as major insulin manufacturers face pressure to lower prices in the US market, creating opportunities for lower-cost alternatives.