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Fresenius Kabi

Fresenius Kabi’s Otulfi (Biosimilar, Stelara) Receives the US FDA’s Interchangeability Designation

Shots:The US FDA has granted interchangeable designation to Otulfi, a biosimilar version of Stelara (ustekinumab) to treat mod. to sev. active Crohn's disease, ulcerative colitis, plaque PsO as well as active PsA, available in the US since March 2025FDA approval was granted in Sep 2024 on the basis of analytical, pre-clinical, clinical & manufacturing data,…

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Fresenius Kabi

Fresenius Kabi Reports the US FDA’s 510(k) Clearance for Adaptive Nomogram, Improving Plasma Collection Efficiency

Shots:The US FDA has granted 510(k) clearance to Adaptive Nomogram algorithm in the Aurora Xi Plasmapheresis System to improve plasma collection efficiency Clearance was based on a trial of Adaptive Nomogram in Aurora Xi Software Version 2.0 vs the existing Optimized Nomogram involving >52,400 procedures that met its 1EP, depicting increased plasma volume…

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Insights+ Key Biosimilars Events of July 2024

Insights+ Key Biosimilars Events of July 2024

Shots:    Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency     Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients     The major highlights were the US FDA’s approval of Samsung Bioepis’ Epysqli for Treating Paroxysmal…

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Insights+ Key Biosimilars Events of September 2023

Insights+ Key Biosimilars Events of September 2023

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potencyBiosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patientsDuring the month of September, Sandoz entered into a development and commercialization agreement…

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Insights+ Key Biosimilars Events of August 2023

Insights+ Key Biosimilars Events of August 2023

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potencyBiosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patientsDuring the month of August, Sandoz’ Tyruko (biosimilar, natalizumab) received the US FDA’s…

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Insights+ Key Biosimilars Events of July 2023

Insights+ Key Biosimilars Events of July 2023

Shots:Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potencyBiosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patientsDuring the month of July, Samsung Bioepis reported P-III equivalence study…

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Insights+ Key Biosimilars Events of February 2023

Insights+ Key Biosimilars Events of February 2023

Shots:Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potencyBiosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patientsDuring the month of February, Alvotech entered into a commercialization agreement…

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