Alvotech Announces Positive Results from Pharmacokinetic Study for Entyvio
Alvotech has reported positive top-line results from a pivotal pharmacokinetic study of AVT80, its proposed biosimilar to Entyvio. The study met all primary endpoints, demonstrating comparable pharmacokinetics, safety, tolerability and immunogenicity to the reference product in healthy adult participants.
Subcutaneous Injection | 06/02/2026 | By News Bureau
Celltrion Gets FDA Nod for 300mg OMLYCLO, the First Interchangeable Xolair Biosimilar
The US FDA has approved 300 mg/2 mL prefilled syringe formulation of OMLYCLO (omalizumab-igec), expanding dosing options for patients with certain allergic diseases and supporting more personalised treatment. OMLYCLO—the first and only biosimilar interchangeable with XOLAIR (omalizumab)—previously received approval for its 75 mg and 150 mg strengths.
Subcutaneous Injection | 03/12/2025 | By Dineshwori | 149
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