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.
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Pricing for Duzallo, a fixed-dose combination of Zurampic (lesinurad) with generic allopurinol, will likely be on par with Zurampic's solo price tag of $371 per month to smooth the way with payers.
US advisory committee strongly endorses cardiovascular risk reduction claim for the GLP-1 agonist but some panelists say new indication should be limited to diabetics with established CV disease, not the broad primary prevention claim Novo Nordisk is seeking.
Presenting equivalence data at EULAR for its biosimilar version of the world's best-selling drug, Humira, Boehringer Ingelheim is optimistic about its position in a crowded field. Karsten Kissel, head of global medical affairs biosimilars for the German group, spoke to Scrip.