Infliximab is a tumor necrosis factor (TNF) blocker monoclonal antibody marketed as Remicade. It is used across immune-mediated diseases including Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis. The FDA first approved infliximab in 1998.
Celltrion released new post-hoc analysis from its phase 3 trial of Remsima SC in IBD patients at the ECCO 2026 congress. The data showed rapid clinical response after treatment gaps and maintained efficacy over 102 weeks. The company also highlighted its unique offering of infliximab in three formulations.
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.
A FAERS database analysis identified 13 FDA-approved systemic medications with disproportionately high uveitis reporting signals among 7,301 events from 2003 to 2024. The strongest signals were for cidofovir and rifabutin, and the findings were described as hypothesis-generating rather than causal.
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The FDA is expected to issue draft guidance reducing testing requirements for biosimilar drugs, potentially lowering development costs by USD 20 million.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.
The global biosimilar market is experiencing robust growth, valued at USD 36.79 billion in 2024 and projected to reach USD 282.3 billion by 2035 at a CAGR of 20.35%, driven by patent expirations, cost pressures, and expanding access to biologic therapies.
New research identifies circulating tumor-reactive T cell characteristics and inflammatory biomarkers as predictive indicators for immune checkpoint inhibitor response in cancer patients, while the PD-L1 testing market is projected to reach $36.44 billion by 2032.
New data from LIBERTY studies show subcutaneous infliximab effectively restored and maintained disease control in Crohn's disease and ulcerative colitis patients after drug holiday of 16 weeks or more, with sustained efficacy through Week 102.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07694674 |
Comparison of the Efficacy of Different Biologic Agents in Preventing Postoperative Endoscopic Recurrence of Crohn's Disease |
RECRUITING | |
| NCT07683975 |
Infliximab for Immune Checkpoint Inhibitor Associated AKI |
NOT_YET_RECRUITING | PHASE4 |
| NCT07657312 |
Infliximab for Cytokine Release Syndrome Prophylaxis During Teclistamab or Talquetamab Therapy in Patients With Relapsed or Refractory Myeloma |
RECRUITING | PHASE2 |
| NCT07619898 |
PHOENIX-ECP- Extracorporeal Photopheresis for Immune-related Colitis and/or Hepatitis in Advanced Melanoma With Inadequate Response to Steroid Exposure |
NOT_YET_RECRUITING | PHASE2 |
| NCT07550673 |
Upadacitinib Versus Infliximab as Second-Line Treatment for Acute Severe Ulcerative Colitis（UPRISE） |
RECRUITING | PHASE4 |
| NCT07491913 |
Biologic Treatment Withdrawal in Takayasu Arteritis Patients in Sustained Remission |
RECRUITING | NA |
| NCT07417696 |
Palmitoleic Acid Combined With Infliximab for Promoting Intestinal Mucosal Healing in Crohn's Disease |
NOT_YET_RECRUITING | PHASE4 |
| NCT07415473 |
Akkermansia Muciniphila Combined With Infliximab for Promoting Intestinal Mucosal Healing in Crohn's Disease |
NOT_YET_RECRUITING | PHASE4 |
| NCT07352566 |
Utilization of a Microdevice for Psoriasis and Atopic Dermatitis |
NOT_YET_RECRUITING | PHASE4 |
| NCT07297069 |
Combination Therapy With Infliximab and Tofacitinib for Acute Severe Ulcerative Colitis - CINTO Trial |
NOT_YET_RECRUITING | PHASE2 |
