Ustekinumab is marketed as STELARA, a human interleukin-12 and interleukin-23 antagonist used in plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. The label includes adult and pediatric indications depending on disease area. U.S. initial approval was in 2009, with indication updates through 2026.
Risankizumab data in Crohn’s disease showed 55% clinical remission at week 12 in AFFIRM, durable efficacy through 148 weeks in SEQUENCE, and the lowest 24-month switch rate in a U.S. claims analysis.
Recent biosimilar and biologic developments included Health Canada approval of denosumab biosimilars, FDA review actions, and new licensing and commercialisation agreements. Other updates covered court, trial and reimbursement agenda decisions.
Alvotech said it will release first-quarter 2026 financial results on May 6, 2026, and host a webcast with live Q&A on May 7. The company said five biosimilars are already approved and marketed, with nine disclosed candidates in development.
The FDA has eased biosimilar approval procedures as these therapies have generated $56 billion in savings since 2015. New guidance eliminates comparative efficacy studies, potentially saving manufacturers $100 million per product and cutting development time by 50%. Despite growth to 23% of the biologics market, a "biosimilar void" threatens $232 billion in missed savings over the next decade.
The FDA is expected to issue draft guidance reducing testing requirements for biosimilar drugs, potentially lowering development costs by USD 20 million. The move comes as the biosimilars market shows strong growth, with major launches in 2025.
Protagonist Therapeutics reported fourth quarter and full year 2025 financial results, with two NDAs submitted and multiple Phase 3 trials advancing. The company holds $646 million in cash and expects regulatory decisions in 2026.
AbbVie announced positive topline results from the Phase 3 AFFIRM study showing risankizumab subcutaneous induction achieved superior clinical remission and endoscopic response rates versus placebo in adults with moderately to severely active Crohn's disease.
Long-term data from the QUASAR extension study show TREMFYA® maintained clinical remission in over 80% of ulcerative colitis patients at Week 140, with more than half achieving endoscopic remission and no new safety concerns observed.
The European Commission has approved Gotenfia (golimumab), a biosimilar to Simponi developed by Bio-Thera and marketed by STADA, for chronic inflammatory autoimmune diseases across the EU and EEA.
The European Commission has granted marketing authorization for Gotenfia, a golimumab biosimilar to Simponi, developed by Bio-Thera and to be commercialized by STADA across the EU, EEA, UK, Switzerland and selected other countries.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07352566 |
Utilization of a Microdevice for Psoriasis and Atopic Dermatitis |
NOT_YET_RECRUITING | PHASE4 |
| NCT07268534 |
Biologics in Folliculitis Decalvans : an Adaptative Trial Research |
NOT_YET_RECRUITING | PHASE2 |
| NCT07177118 |
Risankizumab for Fibrostenotic Crohn's Disease Treatment |
NOT_YET_RECRUITING | PHASE3 |
| NCT07138898 |
Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty |
NOT_YET_RECRUITING | PHASE2 |
| NCT07116967 |
Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK) |
RECRUITING | PHASE3 |
| NCT06934226 |
A Study to Assess Efficacy and Safety of JNJ-77242113 Compared to Placebo and Ustekinumab in Participants With Moderate to Severe Plaque Psoriasis |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT06807593 |
Treatment of Immune Checkpoint Inhibitor-related Diarrhea and/ or Colitis With Ustekinumab in Cancer Patients |
RECRUITING | PHASE2 |
| NCT06520397 |
Efficacy and Safety of Dual-targeted Therapy With Upadacitinib and Ustekinumab Versus Intensified Ustekinumab Therapy in Crohn's Disease |
RECRUITING | PHASE4 |
| NCT06453317 |
Comparison of Ustekinumab, Infliximab and Combination Therapy in Moderately to Severely Active Ulcerative Colitis |
RECRUITING | PHASE2 |
| NCT06425549 |
A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Ustekinumab in Children and Adolescents From 6 Years to Less Than 18 Years of Age With Moderate to Severe Plaque Psoriasis |
RECRUITING | PHASE3 |
