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Clinical Trials
18
4 active
Approvals
0
Total approvals
Agencies
Regulatory bodies
Founded
N/A
Active, not recruiting
2
11.1%
Completed
5
27.8%
Not yet recruiting
Recruiting
6
33.3%
Withdrawn
3
16.7%
No approval data available
- The FDA has approved Garzulys™ (insulin aspart-fsan), a rapid-acting human insulin analog biosimilar to NovoLog®, for glycemic control in adults and pediatric patients with diabetes mellitus. - Meitheal Pharmaceuticals served as the U.S. Regulatory Agent and holds exclusive U.S. commercialization rights under a license agreement with Emerge Bioscience, the BLA holder. - The approval represents a milestone in Meitheal's strategic expansion from generic injectables into complex biologics and branded products. - Garzulys was developed through a multi-company collaboration involving Tonghua Dongbao, NKF, Xentria, and Meitheal, with two additional insulin biosimilar candidates in the pipeline.