Johnson & Johnson’s Tremfya (Guselkumab) Receives the US FDA’s Approval for Pediatric Plaque Psoriasis and Active Psoriatic Arthritis

Shots:FDA has approved Tremfya (SC; Wk. 0, 4 & then Q8W) for children (≥6yrs.; ≥40kg) with mod. to sev. plaque PsO, who are candidates for systemic therapy or phototherapy, or active PsA; an FDA application was also filed to add joint damage inhibition in active PsA adults to Tremfya’s labelPlaque PsO approval was based…

ByRidhi RastogiSeptember 30, 2025

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Bio-Thera Solutions Collaborates with Jamjoom Pharmaceuticals to Commercialize BAT2306 (Biosimilar, Cosentyx)

Shots:Bio-Thera Solutions & Jamjoom Pharmaceuticals have entered into a strategic agreement to commercialize BAT2306, a biosimilar version of Novartis’ Cosentyx (secukinumab) in the Middle East & Africa (MENA)As per the deal, Jamjoom will obtain exclusive MENA rights of BAT2306 to handle regulatory submissions, market access & commercialization, while Bio-Thera will be responsible for development…

ByRidhi RastogiSeptember 15, 2025

NEWS

Polpharma Biologics Enters into Licensing Deals with MS Pharma for Multiple Biosimilar Candidates

Shots:Polpharma has entered into licensing deals with MS Pharma to commercialize PB016 (vedolizumab), PB018 (ocrelizumab), & PB019 (guselkumab) biosimilars across the Middle East & North Africa (MENA) regionAs per the deal, MS Pharma will be responsible for registration, marketing, & distribution of the 3 biosimilars in MENA, while Polpharma will handle development, manufacturing,…

ByRidhi RastogiSeptember 2, 2025

NEWS

Bio-Thera Secures the EC’s Approval for Usymro (Biosimilar, Stelara)

Shots:The EC has approved Usymro (BAT2206), a biosimilar version of J&J’s Stelara (ustekinumab) for all indications of the reference productIn Oct 2024, Bio-Thera & Gedeon Richter entered a licensing & commercialization deal under which Bio-Thera will develop & manufacture Usymro, while Gedeon will commercialize it post-approval & MA Holder transfer in the EU,…

ByRidhi RastogiAugust 27, 2025

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Bristol Myers Squibb and Bain Capital Launch a New Company Focused on Immunology Therapies

Shots:BMS & Bain Capital have launched a new independent biopharma company focused on autoimmune diseases, which will be backed by $300M funding commitment led by Bain & 5 immunology assets in-licensed from BMSAs per the deal, BMS will retain ~20% equity stake in the new company & is entitled to receive royalties & milestone payments for…

ByRidhi RastogiJuly 29, 2025

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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 PsAApproval 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 RastogiJune 16, 2025

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The US FDA Approves Arcutis Biotherapeutics’ Zoryve Topical Foam for Plaque Psoriasis

Shots:FDA has approved sNDA of Zoryve (0.3% roflumilast) for pts (≥12yrs.) with plaque PsO of scalp & body based on P-III (ARRECTOR) & P-II (Trial 204) trials assessing it vs vehicle in 736 pts for 8wks.ARRECTOR met its co-1EPs, with 66.4% vs 27.8% pts achieving Scalp-IGA success & 45.5% vs 20.1% pts attaining…

ByRidhi RastogiMay 23, 2025

NEWS

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

ByRidhi RastogiMay 20, 2025

NEWS

China’s NMPA Approves Akeso’s Ebdarokimab (IL-12/IL-23 Dual-Targeted mAb) for Moderate to Severe Plaque Psoriasis

Shots:Akeso’s ebdarokimab has received NMPA approval for the treatment of moderate-to-severe plaque psoriasis in adultClinical study showed strong efficacy and safety of ebdarokimab (135mg) two doses at weeks 0 and 4, with a PASI 75 response rate of 79.4% at 16wks. and ebdarokimab Q12W 77.9% at 52wks. along with significant improvements in patients'…

ByRidhi RastogiApril 18, 2025

NEWS

China’s NMPA Accepts NDA for Akeso’s Gumokimab to Treat Moderate to Severe Psoriasis

Shots:China’s NMPA has accepted an NDA for gumokimab (AK111) to treat mod. to sev. plaque psoriasis based on the P-III (AK111-301) trial & 3 supportive studies, showing rapid improvement in 2wks. Data showed short-term efficacy, with a PASI 75 response rate approaching 96% & an sPGA 0/1 response nearing 90%. PASI 90 hit ~80%, &…

ByRidhi RastogiJanuary 27, 2025

Johnson & Johnson’s Tremfya (Guselkumab) Receives the US FDA’s Approval for Pediatric Plaque Psoriasis and Active Psoriatic Arthritis

Bio-Thera Solutions Collaborates with Jamjoom Pharmaceuticals to Commercialize BAT2306 (Biosimilar, Cosentyx)

Polpharma Biologics Enters into Licensing Deals with MS Pharma for Multiple Biosimilar Candidates

Bio-Thera Secures the EC’s Approval for Usymro (Biosimilar, Stelara)

Bristol Myers Squibb and Bain Capital Launch a New Company Focused on Immunology Therapies

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

The US FDA Approves Arcutis Biotherapeutics’ Zoryve Topical Foam for Plaque Psoriasis

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

China’s NMPA Approves Akeso’s Ebdarokimab (IL-12/IL-23 Dual-Targeted mAb) for Moderate to Severe Plaque Psoriasis

China’s NMPA Accepts NDA for Akeso’s Gumokimab to Treat Moderate to Severe Psoriasis

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