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FDA Approves First Ustekinumab Biosimilar

The drug has also been granted an interchangeability designation and has been approved for six indications.

United statesSarah yimDrug administrationOffice of therapeutic biologicsTherapeutic biologicsDrug evaluationBiologic therapyBiosimilar drugsFollow on biologicsNt earsPsoriatic arthritisPatient safetyAdverse effectsSide effectsPlaque psoriasisCrohns disease

FDA OKs Ninth Humira Biosimilar, With Interchangeability

The drug, adalimumab-afzb (Abrilada), is the second adalimumab biosimilar approved with interchangeability status. It will be available later this month.

United statesUniversity of texas southwestern medical centerRoy fleischmannDrug administrationTexas southwestern medical centerRheumatoid arthritisBiologic therapyBiosimilar drugsFollow on biologicsPsoriatic arthritisHidradenitis suppurativaUlcerative colitisAnkylosing spondylitisCrohns diseaseAnkylosing spondylitis bechterews diseaseAxial spondyloarthritis axspa

European Commission Approves First Tocilizumab Biosimilar

The biosimilar, commercially called Tyenne, is indicated to treat several autoimmune diseases as well as cytokine release syndrome and COVID-19.

Fresenius kabiPierluigi antonelliDrug administrationEuropean medicines agencyEuropean commissionEuropean unionChief executive officer pierluigi antonelliBiologic license applicationRheumatoid arthritisBiologic therapyBiosimilar drugsFollow on biologicsInterleukin antagonistL antagonistCovid 19 treatmentJuvenile rheumatoid arthritis

FDA Okays First Biosimilar for Multiple Sclerosis

Sandoz s natalizumab-sztn injection (Tyruko) is on par with Biogen s Tysabri (natalizumab) for treatment of relapsing forms of MS, the FDA said in approving the first biosimilar to treat MS.

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US FDA Approves Regeneron s Ultra-Rare Blood Disease Drug

Regeneron Pharmaceuticals said on Friday the U.S. health regulator approved its drug to treat a rare blood disease.

Shilpi majumdarVaibhav sadhamtaPratik jainKhushi mandowaraEvan seigermanRegeneron pharmaceuticalsDrug administrationBiologic therapyGenomic medicineEdicine genomicMeningococcal infectionMeningococcal diseasePractice managementBiosimilar drugsFollow on biologics

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