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

NEWS

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

NEWS

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

NEWS

Johnson & Johnson Highlights P-III Clinical Data of Icotrokinra for Plaque Psoriasis at AAD 2025

Shots: J&J has reported P-III trial data incl. ICONIC-LEAD (vs PBO) & ICONIC-ADVANCE 1&2 (vs Sotyktu) assessing icotrokinra (JNJ-2113, QD, PO) to treat mod. to sev. plaque Ps OICONIC-LEAD showed that pts achieved IGA 0/1 (65% vs 8%) & reached PASI 90 (50% vs 4%) at 16wks. By Wk. 24, 74% achieved IGA 0/1,…

ByRidhi RastogiMarch 10, 2025

NEWS

Biocon Biologics Report the P-III Study Positive Results of Yesintek (Biosimilar, Stelara)

Shots: Biocon Biologics revealed positive results from the P-III study demonstrating that Yesintek achieved equivalent efficacy, safety, immunogenicity, and PK vs reference product to treat mod. to sev. chronic plaque psoriasis (PsO) pts. (n=384, age= 18-80yrs.); data was presented at AAD 2025 The primary efficacy endpoint, percentage change in PASI scores at Wk. 12 showed…

ByDipanshu DixitMarch 7, 2025

NEWS

Fresenius Kabi Launches Otulfi (Biosimilar, Stelara) in the US

Shots: Fresenius Kabi has launched Otulfi (ustekinumab- aauz) injection, a biosimilar to Stelara, developed by Formycon AG to treat mod. to sev. Crohn’s disease, ulcerative colitis, and plaque psoriasis & active psoriatic arthritis (age ≥ 6 yrs.) across the US Otulfi will be available in the US in 45 mg/0.5 mL and 90 mg/mL prefilled…

ByDipanshu DixitMarch 3, 2025

NEWS

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

Shots: The UK’s MHRA has approved Otulfi (SC & IV), biosimilar of J&J’s Stelara (ustekinumab), to treat mod. to sev. active Crohn's disease, ulcerative colitis, plaque psoriasis as well as active psoriatic arthritis & is set to enter UK market as per a confidential settlement b/w the companies and J&J. It is approved across the US,…

BySenior EditorJanuary 16, 2025

INSIGHTS+

Key Biosimilars Events of December 2024

Shots: Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients A major highlight was the US FDA’s approval of Biocon Biologics’ Yesintek…

ByDipanshu DixitJanuary 7, 2025

INSIGHTS+

Key Biosimilars Events of December 2024

Shots: Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency   Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients   A major highlight was the US FDA’s approval of Biocon Biologics’ Yesintek…

ByDipanshu DixitJanuary 7, 2025

VIEWPOINTS

Biocon Biologics at EADV Congress 2024: Uwe Gudat in a Stimulating Dialogue Exchange with PharmaShots

Shots: At the European Academy of Dermatology and Venereology (EADV) 2024 Congress, Biocon Biologics presented results from two pivotal P-III clinical studies. These studies supported the interchangeability between Humira and adalimumab-fkjp, as well as the biosimilarity between Bmab 1200 and Stelara for the treatment of patients with moderate-to-severe plaque psoriasis In an engaging conversation with…

BySaurabh ChaubeyJanuary 6, 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

Johnson & Johnson Highlights P-III Clinical Data of Icotrokinra for Plaque Psoriasis at AAD 2025

Biocon Biologics Report the P-III Study Positive Results of Yesintek (Biosimilar, Stelara)

Fresenius Kabi Launches Otulfi (Biosimilar, Stelara) in the US

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

Key Biosimilars Events of December 2024

Key Biosimilars Events of December 2024

Biocon Biologics at EADV Congress 2024: Uwe Gudat in a Stimulating Dialogue Exchange with PharmaShots

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