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USFDA gives nod to first interchangeable biosimilar for two rare diseases

USFDA gives nod to first interchangeable biosimilar for two rare diseases
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Sarah yimBkemv to amgen incDrug administrationOffice of therapeutic biologicsTherapeutic biologicsDrug evaluationGovt run janaushadhiDry eyeBoxed warningBkemv risk evaluationMitigation strategy

MIL-OSI USA: FDA Approves First Interchangeable Biosimilar for Two Rare Diseases

Foreign Affairs Provides up to the minute Raw News, reportage, current affairs, Open Source Intelligence, OSI, Information, Analysis, and Essays, all published with immediacy at the time of relevancy

Sarah yimBkemv to amgen incHuman servicesDrug administrationUs department of healthOffice of therapeutic biologicsFor immediate releaseTherapeutic biologicsDrug evaluationBoxed warningBkemv risk evaluationMitigation strategy

FDA Approves First Interchangeable Biosimilar for Two Rare Diseases

FDA approved Bkemv as the first interchangeable biosimilar to Soliris (eculizumab) to treat certain rare diseases. Bkemv is approved for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH); and atypical hemolytic uremic syndrome (aHUS).

Sarah yimUs department of healthBkemv to amgen incDrug administrationOffice of therapeutic biologicsHuman servicesFor immediate releaseTherapeutic biologicsDrug evaluationBoxed warningBkemv risk evaluationMitigation strategy

FDA Approves First Interchangeable Biosimilar for Two Rare Diseases

/PRNewswire/ Today, the U.S. Food and Drug Administration approved Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab).

Cherie duvall jonesSarah yimOffice of therapeutic biologicsDrug administrationBkemv to amgen incTherapeutic biologicsDrug evaluationBoxed warningBkemv risk evaluationMitigation strategy