The US Food and Drug Administration (FDA) has approved Meitheal Pharmaceuticals’ Garzulys (insulin aspart-fsan), a rapid-acting insulin biosimilar to NovoLog (insulin aspart).

Garzulys is indicated to improve glycemic control in adults and paediatric patients with diabetes mellitus. The insulin is approved for both subcutaneous and intravenous administration.

Meitheal serves as the US regulatory agent for Garzulys and holds exclusive US commercialisation rights under a licensing agreement with Emerge Bioscience, which holds the approved Biologics License Application (BLA) for the product.

The FDA approval expands the availability of insulin aspart treatment and marks Meitheal’s move further into biologic medicines alongside its established generic injectable portfolio.

Garzulys developed through international collaboration

Garzulys was developed through a collaboration involving Tonghua Dongbao Pharmaceutical, Nanjing King-Friend Biochemical Pharmaceutical (NKF), Xentria and Meitheal, with Emerge responsible for holding the BLA and key supply-chain activities.

Tonghua Dongbao was responsible for drug substance development, while NKF led drug product development. Xentria led the clinical development programme and Meitheal, as US regulatory agent, led the regulatory work supporting the FDA approval.

The collaboration between Tonghua Dongbao and NKF, which began in 2023, covers Garzulys and two additional insulin biosimilar candidates currently in development.

Through its exclusive licence agreement with Emerge, Meitheal holds US commercialisation rights for Garzulys and the two additional candidates.

Tom Shea, CEO of Meitheal, said: “The FDA approval of Garzulys represents an important milestone in Meitheal’s continued expansion beyond our established generic injectable business and into a broader portfolio of biologics and branded products.”

He added that the company was continuing to invest in regulatory expertise, commercial infrastructure and strategic partnerships to expand access to biologic medicines.

Rapid-acting insulin approved for diabetes

Garzulys is a rapid-acting human insulin analogue designed to improve glycaemic control in adults and paediatric patients with diabetes mellitus.

As a biosimilar to NovoLog, Garzulys is based on insulin aspart, a rapid-acting insulin analogue used in diabetes treatment.

The FDA approval allows the product to be administered by subcutaneous injection and intravenously, according to its approved indication.

Biosimilars are biological medicines that have been shown to be highly similar to an FDA-approved reference biological product, with no clinically meaningful differences in terms of safety and effectiveness for their approved uses.

The approval adds another insulin biosimilar to the US market and gives Meitheal exclusive commercialisation rights for the product.

Meitheal expands biologics portfolio

The approval is part of Meitheal’s broader strategy to expand beyond generic injectable medicines into biologics and branded products.

The company said its platform now supports more than 80 FDA-approved products across therapeutic areas including anti-infectives, oncology, anaesthesia, diabetes, critical care and fertility.

The Garzulys collaboration also includes two additional insulin biosimilar candidates that remain in development, potentially creating a wider insulin portfolio for Meitheal and its partners.

For patients and healthcare providers, the availability of additional biosimilar insulin products could contribute to greater choice within the US diabetes treatment market.

The FDA approval therefore represents both a regulatory milestone for Garzulys and a further expansion of Meitheal’s US biologics portfolio, while the wider collaboration demonstrates the role of partnerships between pharmaceutical companies in developing and bringing biosimilar medicines to market.