Sandoz Launches Pyzchiva Autoinjector (Biosimilar, Stelara) in the EU for Chronic Inflammatory Diseases

Shots: Sandoz has launched Pyzchiva autoinjectors, a biosimilar version of Stelara (ustekinumab) in EU to treat pts (≥6yrs.; ≥60kg) with plaque PsO, PsA, Crohn’s disease & pediatric plaque PsO; commercially available in Spain, with further expansion to continue In Sep 2023, Sandoz & Samsung Bioepis entered into a development & commercialization agreement, granting Sandoz rights to…

ByRidhi RastogiMay 23, 2025

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Celltrion launches SteQeyma (Biosimilar, Stelara) in the US

Shots: Celltrion has launched SteQeyma (ustekinumab-stba) injection, a biosimilar to Stelara, for all indications of the reference products following the US FDA’s approval in Dec 2024 Approval was supported by various clinical evidence incl. P-III trial of SteQeyma vs Stelara for mod. to sev. plaque PsO, with 1EP as rate of change in the PASI for skin…

ByRidhi RastogiMarch 17, 2025

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Sandoz Launches Pyzchiva (Biosimilar, Ustekinumab-ttwe) in the US for Chronic Inflammatory Diseases

Shots: Sandoz has launched Pyzchiva, a biosimilar version of Stelara in the US to treat mod. to sev. plaque PsO & active PsA in adults as well as pediatric pts, plus mod. to sev. active crohn’s disease & UC in adults; expected to offer interchangeability by H1'25 Launch follows Samsung’s settlement & license deal…

ByRidhi RastogiFebruary 25, 2025

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The US FDA Approves High Concentration of Boehringer Ingelheim’s Cyltezo (Biosimilar, Humira)

Shots: Boehringer Ingelheim has received the US FDA’s approval for the high-concentration (100mg/mL), citrate-free formulation of Cyltezo (biosimilar to Humira) to treat various chronic inflammatory diseases. Its low concentration of 50mg/mL has been available since Jul 2023 The approval was supported partly by the data from P-I (VOLTAIRE-HCLF) evaluating the bioavailability of high-concentration vs low-concentration…

ByDipanshu DixitMay 1, 2024

Sandoz Launches Pyzchiva Autoinjector (Biosimilar, Stelara) in the EU for Chronic Inflammatory Diseases

Celltrion launches SteQeyma (Biosimilar, Stelara) in the US

Sandoz Launches Pyzchiva (Biosimilar, Ustekinumab-ttwe) in the US for Chronic Inflammatory Diseases

The US FDA Approves High Concentration of Boehringer Ingelheim’s Cyltezo (Biosimilar, Humira)

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Sandoz Launches Pyzchiva Autoinjector (Biosimilar, Stelara) in the EU for Chronic Inflammatory Diseases

Celltrion launches SteQeyma (Biosimilar, Stelara) in the US

Sandoz Launches Pyzchiva (Biosimilar, Ustekinumab-ttwe) in the US for Chronic Inflammatory Diseases

The US FDA Approves High Concentration of Boehringer Ingelheim’s Cyltezo (Biosimilar, Humira)

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