The US FDA Approves Additional Presentation of Celltrion’s Steqeyma (Biosimilar, Stelara)

Shots: The US FDA has approved Steqeyma (45mg/0.5mL, SC, single-dose vial), a biosimilar version of Stelara (ustekinumab) for the treatment of pts (6-17yrs.; ≤60kg) with plaque PsO or PsA Approval was supported by extensive clinical data, incl. P-III trial of Steqeyma vs Stelara for mod. to sev. plaque PsO, with 1EP as rate of change…

ByRidhi Rastogi3 days ago

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Samsung Bioepis Collaborates with NIPRO to Commercialize Biosimilar Candidates in Japan

Shots: Samsung Bioepis & NIPRO have entered into a license, development & commercialization agreement for various biosimilar candidates, incl. SB17, a biosimilar version of Stelara (ustekinumab) in Japan As per the deal, NIPRO will be responsible for commercialization of the biosimilar candidates in Japan, with Samsung Bioepis handling development, manufacturing & supply activities Ustekinumab is…

ByRidhi RastogiJune 9, 2025

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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 product Approval 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…

ByRidhi RastogiMay 27, 2025

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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 2025 FDA approval was granted in Sep 2024 on the basis of analytical, pre-clinical, clinical & manufacturing data,…

ByRidhi RastogiMay 20, 2025

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Johnson & Johnson Reveals P-III (ICONIC-TOTAL) Trial Data of Icotrokinra for Plaque Psoriasis

Shots: J&J has reported P-III (ICONIC-TOTAL) trial data assessing icotrokinra (QD, PO; n=208) vs PBO (n=103) in 311 PsO pts (≥12yrs.) with ≥1% body surface area & at least mod. plaque PsO at high-impact sites At Wk. 16, trial met its 1EP, with 57% vs 6% achieving IGA 0/1 & ≥2-grade improvement while in scalp…

ByRidhi RastogiMay 12, 2025

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Teva and Alvotech’s Selarsdi (Biosimilar, Stelara) Receives the US FDA’s Interchangeability Designation

Shots: The US FDA has granted interchangeable designation to Selarsdi, a biosimilar version of Stelara (ustekinumab) for all indications incl. treatment of adult & pediatric PsA & plaque PsO as well as Crohn’s disease, & ulcerative colitis, effective as of Apr 30, 2025 Selarsdi is an anti-IL-12/IL-23 mAb, with 4 approved presentations: 45mg/0.5mL & 90mg/mL…

ByRidhi RastogiMay 6, 2025

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Top 20 Biopharma Companies of 2025

Shots: Driven by innovation and a steadfast commitment to advancing cutting-edge therapies, the biopharma industry experienced robust growth in 2024, marked by significant revenue milestones With a projected compound annual growth rate (CAGR) of 12.87%, the global biopharma market is expected to reach $1.41 trillion by 2032. In 2024, Pfizer led the industry with total…

ByPrince GiriApril 24, 2025

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Johnson & Johnson Reveals P-III (ICONIC-LEAD) Trial Data of Icotrokinra for Plaque Psoriasis

Shots: J&J has reported subgroup analysis from P-III (ICONIC-LEAD) trial assessing icotrokinra (QD, PO; n=456) vs PBO (n=228) in 684 adolescents & adults with mod. to sev. plaque PsO At Wk. 16, 84.1% adolescent achieved IGA 0/1 vs 27.3%, & 70.5% vs 13.6% reached PASI 90. By Wk. 24, 86.4% achieved IGA 0/1, 88.6% reached PASI…

ByRidhi RastogiApril 11, 2025

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Celltrion’s Steqeyma (Biosimilar, Stelara) Adds into the Costco Member Prescription Program

Shots: Celltrion announced that Steqeyma (ustekinumab-stba), a biosimilar to Stelara, has been added to the Costco Member Prescription Program. It was launched on Mar 12, 2025. Celltrion's adalimumab-aaty was added to the program in Aug 2024 Steqeyma will be available in the US from Costco Specialty Pharmacies on Apr 1, 2025, for self-funded employer plans,…

ByDipanshu DixitMarch 28, 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

The US FDA Approves Additional Presentation of Celltrion’s Steqeyma (Biosimilar, Stelara)

Samsung Bioepis Collaborates with NIPRO to Commercialize Biosimilar Candidates in Japan

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

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

Johnson & Johnson Reveals P-III (ICONIC-TOTAL) Trial Data of Icotrokinra for Plaque Psoriasis

Teva and Alvotech’s Selarsdi (Biosimilar, Stelara) Receives the US FDA’s Interchangeability Designation

Top 20 Biopharma Companies of 2025

Johnson & Johnson Reveals P-III (ICONIC-LEAD) Trial Data of Icotrokinra for Plaque Psoriasis

Celltrion’s Steqeyma (Biosimilar, Stelara) Adds into the Costco Member Prescription Program

Celltrion launches SteQeyma (Biosimilar, Stelara) in the US

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