Amgen's Amjevita Approved As First Biosimilar To AbbVie's Humira
Adalimumab-atto is approved for seven indications on the reference product label but lacks four others that are protected by orphan product exclusivity; launch timing is unclear due 'patent dance' litigation.
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US Approvals Roundup: Cyltezo Biosimilar, Victoza CV Benefit, Gocovri In PD, Kedrab Rabies Biologic, Gout Combo Duzallo
FDA's clearances showcase the application of formulation technology to reduce problem side effects and improve convenience of available drugs.