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Bio-Thera & Hikma

Bio-Thera Solutions and Hikma Pharmaceuticals Receive the US FDA’s Approval for Starjemza (Biosimilar, Stelara)

Shots:The US FDA has approved Starjemza (BAT2206), a biosimilar version of Stelara (ustekinumab) for all indications of the reference productApproval was based on comprehensive analytical, non-clinical, & clinical data incl. extensive analytical characterization, P-I trial in healthy subjects & P-III trial in mod. to sev. plaque PsO pts, showing similar efficacy, safety, PK…

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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 June 2023

Insights+ Key Biosimilars Events of June 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 June, Samsung Bioepis presented results of SB12…

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