Shots: The CHMP has granted a positive opinion to Fresenius & Formycon’s FYB202, a biosimilar version of Stelara (ustekinumab), with the decision anticipated during Q4’24 The opinion was supported by non-clinical & clinical studies plus manufacturing data, depicting similar effectiveness, safety & PK profile of FYB202 vs Stelara among moderate to severe psoriasis vulgaris (plaque psoriasis)…

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Bio-Thera Reports the Regulatory Filing Acceptance for BAT2206 (Biosimilar, Stelara) Across the US and EU

Shots: The US FDA and EMA have accepted the BLA & MAA of BAT2206 for treating moderate to severe plaque PsO in adults eligible for phototherapy or systemic therapy, active PsA, moderate to severe active CD & moderate to severe active ulcerative colitis. BLA in China is under review The applications were supported by…

ByDipanshu DixitJuly 24, 2024

Fresenius Kabi and Formycon Report the CHMP’s Positive Opinion of FYB202 (Biosimilar, Stelara)

Bio-Thera Reports the Regulatory Filing Acceptance for BAT2206 (Biosimilar, Stelara) Across the US and EU

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