Biocon’s Yesintek (Biosimilar, Stelara) Receives Health Canada Approval for its Autoinjector Presentation

Shots: Health Canada has approved Yesintek Autoinjector (45 mg/0.05 mL & 90 mg/mL), a biosimilar version of Stelara (ustekinumab) Yesintek is indicated for the treatment of mod. to sev. plaque psoriasis in pts (≥6yrs.), active psoriatic arthritis in adults, mod. to sev. active Crohn’s disease & ulcerative colitis in adults Yesintek was previously approved as…

ByRidhi Rastogi17 hours ago

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Takeda Reports the P-III (LATITUDE) Studies Data on Zasocitinib in Plaque Psoriasis

Shots: Takeda has reported the 2 P-III (Latitude PsO 3001 & PsO 3002) trial results assessing zasocitinib (QD, PO) in 693 & 1108 adults, respectively, with mod. to sev. PsO, where both studies showed improved NAPSI scores vs PBO at 16wks. Trials also showed that 77% (3001) & 74% (3002) pts reached ssPGA 0/1 response…

ByRidhi RastogiJuly 17, 2026

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Samsung Bioepis Introduces its Ustekinumab Biosimilar in Japan with NIPRO CORPORATION

Shots: Samsung Bioepis has reported the launch of Ustekinumab BS 45 mg Syringe for SC Injection 「NIPRO」, a biosimilar version of Stelara, in Japan, marking the company’s first commercialized product in the country The biosimilar will be commercialized by NIPRO CORPORATION under a strategic partnership between Samsung Bioepis & NIPRO in 2025, focused on developing &…

ByRidhi RastogiMay 20, 2026

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UCB Reports P-III (BE BOLD) Trial Data on Bimzelx in Active Psoriatic Arthritis

Shots: UCB has reported the (BE BOLD) trial data assessing Bimzelx(bimekizumab-bkzx) vs Skyrizi(risankizumab-rzaa) in 553 adults living with active psoriatic arthritis (PsA) Trial met its 1EP, with 49.1% pts achieving ACR50 at Wk. 16 vs 38.4%. The first ranked 2EP, MDA was numerically higher at Wk. 16 (43% vs 39.9%), but did not reach statistical…

ByRidhi RastogiMay 20, 2026

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BMS’ Sotyktu (Deucravacitinib) Wins EC Approval to Treat Adults with Active Psoriatic Arthritis (PsA)

Shots: FDA has approved BMS' Sotyktu (6mg, PO, QD) ± methotrexate for adults with active PsA who have had an inadequate response or were intolerant to a prior disease-modifying antirheumatic (DMARD) therapy Approval was based on P-III trials, incl. POETYK PsA-1, involving 670 bDMARD-naïve pts, and POETYK PsA-2, involving 624 pts who were bDMARD-naïve &…

ByRidhi RastogiMay 11, 2026

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BMS’ Sotyktu (Deucravacitinib) Wins FDA Approval to Treat Adults with Active Psoriatic Arthritis (PsA)

Shots: FDA approved Sotyktu(6mg, PO, QD) for adults with active PsA based on 2 P-III trials against PBO, with POETYK PsA-1 involving 670 bDMARD-naïve pts while POETYK PsA-2 involved 624 pts who were bDMARD-naïve & treated with prior TNFα inhibitor POETYK PsA-1 showed that 54% pts achieved ACR20 compared to 34%, while 24% vs 14%…

ByRidhi RastogiMarch 9, 2026

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Dr. Reddy’s Reports the US FDA’s BLA Acceptance for DRL_AB (Biosimilar, Orencia)

Shots: The US FDA has accepted 351 (k) BLA for DRL_AB (IV), a proposed interchangeable biosimilar to Orencia (abatacept) Upon approval, DRL_AB will be indicated for adults with mod. to sev. active rheumatoid arthritis, adults with active psoriatic arthritis, & pts (≥6yrs.) with mod. to sev. active polyarticular juvenile idiopathic arthritis BLA was supported by extensive…

ByRidhi RastogiFebruary 23, 2026

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Eli Lilly Reports P-IIIb (TOGETHER-PsA) Trial on Taltz + Zepbound for Psoriatic Arthritis and Obesity or Overweight

Shots: Eli Lilly has reported P-IIIb (TOGETHER-PsA) trial assessing concomitant Taltz (ixekizumab) & Zepbound (tirzepatide) vs Taltz alone in 271 adults with active PsA & obesity or overweight with ≥1 weight-related condition Trial met its 1EP, with 31.7% of pts achieving ACR50 & ≥10% weight loss at Wk. 36 vs 0.8%, & met a key…

ByRidhi RastogiJanuary 9, 2026

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Samsung Bioepis’ Ustekinumab BS (Biosimilar, Stelara) Approved in Japan

Shots: Samsung Bioepis has received Japanese marketing approval for Ustekinumab BS 45mg syringes, a biosimilar of Stelara, under its partnership with NIPRO Corporation Ustekinumab, a human IgG1κ antibody targeting IL-12/IL-23, is approved in Japan as ‘NIPRO’ for plaque psoriasis and psoriatic arthritis, with NHI listing expected in May 2026 It is also approved in Australia, Brazil, Canada,…

ByDipanshu DixitDecember 23, 2025

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Takeda Reports Topline P-III (LATITUDE) Trials Findings on Zasocitinib in Plaque Psoriasis (PsO)

Shots: Takeda has reported data from 2 global P-III trials (NCT06088043 & NCT06108544) assessing zasocitinib (TAK-279) vs apremilast & PBO in 693 & 1108 adult pts, respectively, with mod. to sev. PsO Trial showed superiority to PBO on co-1EPs (sPGA 0/1 & PASI 75) at Wk. 16, with early PASI 75 responses from Wk. 4, sustained…

ByRidhi RastogiDecember 18, 2025

Biocon’s Yesintek (Biosimilar, Stelara) Receives Health Canada Approval for its Autoinjector Presentation

Takeda Reports the P-III (LATITUDE) Studies Data on Zasocitinib in Plaque Psoriasis

Samsung Bioepis Introduces its Ustekinumab Biosimilar in Japan with NIPRO CORPORATION

UCB Reports P-III (BE BOLD) Trial Data on Bimzelx in Active Psoriatic Arthritis

BMS’ Sotyktu (Deucravacitinib) Wins EC Approval to Treat Adults with Active Psoriatic Arthritis (PsA)

BMS’ Sotyktu (Deucravacitinib) Wins FDA Approval to Treat Adults with Active Psoriatic Arthritis (PsA)

Dr. Reddy’s Reports the US FDA’s BLA Acceptance for DRL_AB (Biosimilar, Orencia)

Eli Lilly Reports P-IIIb (TOGETHER-PsA) Trial on Taltz + Zepbound for Psoriatic Arthritis and Obesity or Overweight

Samsung Bioepis’ Ustekinumab BS (Biosimilar, Stelara) Approved in Japan

Takeda Reports Topline P-III (LATITUDE) Trials Findings on Zasocitinib in Plaque Psoriasis (PsO)

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