Meitheal Pharmaceuticals Reports US FDA Approval of High-Concentration Formulation of Yusimry (Biosimilar, Humira)

Shots The US FDA has approved a citrate-free, high-concentration formulation for Yusimry as an interchangeable biosimilar to Humira (adalimumab) Yusimry, a TNF blocker, is available in low and high concentration formulations via autoinjector, with the low-concentration formulation also available as a PFS Emerge Bioscience holds the approved BLA for Yusimry, while Meitheal serves as its…

ByRidhi RastogiSeptember 30, 2026

Meitheal Secures FDA Approval for Garzulys (Biosimilar, NovoLog)

Shots: 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…

ByRidhi RastogiAugust 3, 2026

Insights+ Key Biosimilars Events of September 2023

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients During the month of September, Sandoz entered into a development and commercialization agreement…

BySenior EditorOctober 4, 2023

Meitheal Pharmaceuticals Reports US FDA Approval of High-Concentration Formulation of Yusimry (Biosimilar, Humira)

Meitheal Secures FDA Approval for Garzulys (Biosimilar, NovoLog)

Insights+ Key Biosimilars Events of September 2023

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