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The US FDA has approved Garzulys (SC & IV), a biosimilar to NovoLog (insulin aspart) to improve glycemic control in adults & pediatric pts with diabetes mellitus
Garzulys was developed through a collaboration among Tonghua Dongbao, NKF, Xentria, Meitheal, & Emerge. Tonghua Dongbao developed the drug substance, NKF the drug product, Xentria led clinical development, Meitheal managed US regulatory activities, & Emerge is the BLA holder
The 2023 Tonghua Dongbao–NKF collaboration incl. Garzulys & 2 insulin biosimilar candidates in development. Through its license with Emerge, Meitheal holds exclusive US commercialization rights for Garzulys & both pipeline candidates
Ref: Businesswire | Image: Meitheal | Press Release
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The post Meitheal Secures FDA Approval for Garzulys (Biosimilar, NovoLog) appeared first on PharmaShots.
Meitheal Secures FDA Approval for Garzulys (Biosimilar, NovoLog) | PharmaVoice