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Formycon and Fresenius Kabi
NEWS

Fresenius Kabi and Formycon Report the US FDA’s Approval of Otulfi (Biosimilar, Stelara) 

Shots:  The US FDA has approved Otulfi (SC & IV), biosimilar of Stelara (ustekinumab), to treat Crohn’s disease, ulcerative colitis, mod. to sev. plaque PsO & active psoriatic arthritis. Fresenius Kabi can market Otulfi by Feb 22, 2025  Approval was based on analytical, pre-clinical, clinical & manufacturing data, showing similar efficacy, safety, PK & immunogenicity…
September 30, 2024

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Formycon and Fresenius Kabi
NEWS

Formycon and Fresenius Kabi Reports the EC’s Approval of Otulfi (Biosimilar, Stelara) for Serious Inflammatory Diseases 

Shots:  The EC has approved Otulfi (IV/SC), a biosimilar of Stelara (ustekinumab), to treat mod. to sev. active CD, mod. to sev. plaque PsO & active PsA, valid across EU as well as Iceland, Liechtenstein & Norway  Approval was based on analytical, pre-clinical, clinical & manufacturing data, depicting similar effectiveness, safety & PK profile of…
September 27, 2024

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Formycon and Fresenius Kabi
NEWS

Formycon and Fresenius Kabi Reports the EC’s Approval of Otulfi (Biosimilar, Stelara) for Serious Inflammatory Diseases   

Shots:  The EC has approved Otulfi (IV/SC), a biosimilar of Stelara (ustekinumab), to treat mod. to sev. active CD, mod. to sev. plaque PsO & active PsA, valid across EU as well as Iceland, Liechtenstein & Norway  Approval was based on analytical, pre-clinical, clinical & manufacturing data, depicting similar effectiveness, safety & PK profile of…
September 27, 2024

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Celltrion
NEWS

Celltrion’s SteQeyma (Biosimilar, Stelara) Receives the EC’s Approval to Treat Various Chronic Inflammatory Diseases 

Shots:  Following the CHMP’s positive opinion in Jun 2024, the EC has approved SteQeyma, a biosimilar version of Stelara (ustekinumab), for treating various chronic inflammatory diseases. Approved as biologic for gastroenterology, dermatology & rheumatology indications  Approval was supported by the P-III trial of SteQeyma vs Stelara for moderate to severe plaque PsO, with 1EP as…
August 26, 2024

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Celltrion
NEWS

Celltrion’s Steqeyma (Biosimilar, Stelara) Receives the Health Canada’s Approval to Treat Various Chronic Inflammatory Conditions 

Shots:  Health Canada has approved Steqeyma injection & Steqeyma I.V. (injection, solution for IV infusion), biosimilar versions of Stelara (ustekinumab) to treat adults with moderate to severe active Crohn’s disease & plaque PsO as well as active psoriatic arthritis  Approval was supported by the P-III trial of Steqeyma vs Stelara, with the 1EP as rate…
August 1, 2024

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Formycon and Fresenius Kabi
NEWS

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

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)…
July 26, 2024

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NEWS

STADA and Alvotech Introduces Uzpruvo (Biosimilar, Stelara) Across the EU

Shots:    The company has introduced Uzpruvo, biosimilar of Stelara (ustekinumab) across the EU to treat gastroenterology, dermatology & rheumatology indications. Uzpruvo is available in a pre-filled syringes with a thinner needle & is latex-free to avoid allergic reactions   Further EU launches are expected in the upcoming mos., pending national price approvals through a fully European supply…
July 22, 2024

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