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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 Eculizumab-Aeeb as Interchangeable Biosimilar for 2 Rare Diseases

Eculizumab-aeeb (Bkemv; Amgen) is approved for the treatment of paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.

Sarah yimOffice of therapeutic biologicsAstrazeneca rare diseaseTherapeutic biologicsDrug evaluation

Two novel biosimilars approved in EU and US

The first omalizumab biosimilar in allergic diseases is approved by the EC and US FDA has authorised the fifty third biosimilar in the US.

Sarah yimMarcus maurerAmgen bkemvDrug administrationInstitute of allergologyOffice of therapeutic biologicsEuropean commissionProfessor marcus maurerFraunhofer siteFraunhofer translational medicineExecutive directorAlexion pharmaceuticalTherapeutic biologicsDrug evaluation

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

FDA investigators find no safety risks when switching between biologics, biosimilars

FDA investigators find no safety risks when switching between biologics, biosimilars
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Thomasm herndonShenaz baghaBysara kellnerOffice of therapeutic biologicsTherapeutic biologics

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