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FDA approves first Stelara biosimilar, Wezlana

FDA approves first Stelara biosimilar, Wezlana
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United statesJohnson stelaraAmgen wezlanaNikolay nikolovOffice of immunologyDrug administrationDrug evaluation

FDA Approves Interchangeable Biosimilar for Multiple Inflammatory Diseases

The FDA approved Wezlana, an interchangeable biosimilar to Stelara for multiple inflammatory diseases.

Sarah yimNikolay nikolovOffice of immunologyDrug administrationHuman servicesWezlana to amgen incOffice of therapeutic biologicsUs department of healthFor immediate releaseDrug evaluationTherapeutic biologicsPosterior reversible encephalopathy syndromeMedication guide

FDA Approves Interchangeable Biosimilar to Ustekinumab

The FDA announced the approval of ustekinumab-auub (Wezlana) as a biosimilar and interchangeable to ustekinumab (Stelara) for a half dozen inflammatory conditions on October 31, 2023.

Sarah yimNikolay nikolovDrug administrationOffice of the commissionerOffice of immunologyJanssen biotech incOffice of therapeutic biologicsAmgen incDrug evaluationTherapeutic biologicsAccessed octoberJanssen biotech

FDA Approves Interchangeable Biosimilar Ustekinumab-auub for Inflammatory Diseases

The biosimilar, now legally available at the pharmacy level, demonstrated similar safety, purity, and potency to the reference product.

Sarah yimNikolay nikolovOffice of immunologyOffice of therapeutic biologicsTherapeutic biologicsDrug evaluationMedication guide

Interchangeable Biosimilar Wezlana Gets FDA Approval

The FDA has approved Wezlana (ustekinumab-auub), a biosimilar product interchangeable with Stelara (ustekinumab).

Nikolay nikolovOffice of immunologyDrug administrationDrug evaluation

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