Adalimumab is a monoclonal antibody biologic, sold as Humira, used across multiple inflammatory and autoimmune diseases. It is a TNF inhibitor administered subcutaneously and was approved for medical use in the United States in 2002. It is also available as biosimilar products.
Xolair may be dropped from Medicare price negotiations as a biosimilar launch looms. The CMS must decide if the biosimilar is a true competitor. The outcome could set precedent for future biosimilar-facing selections.
The European Commission granted marketing authorization to Sandoz for Bysumlog (insulin lispro) and Dazparda (insulin aspart), two biosimilar insulins developed by Gan & Lee Pharmaceuticals. A recent HHS analysis found most biosimilar markets become economically unviable after five competitors, prompting companies to diversify portfolios. Accord aims to bring 20 biosimilars to market by 2030.
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.
Global biologics market projected to grow to USD 1.28 trillion by 2035; Japan cell and gene therapy market to reach USD 2.15 billion by 2034; Japan biologic drug lifecycle management market to hit USD 9.69 billion by 2033.
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The FDA is expected to issue draft guidance reducing testing requirements for biosimilar drugs, potentially lowering development costs by USD 20 million.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.
Dr. Reddy's Laboratories secures FDA acceptance for DRL-AB, the first abatacept biosimilar application in the U.S., targeting a market worth $3.7 billion annually and positioning the company for first-mover advantage.
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 |
|---|---|---|---|
| NCT07694674 |
Comparison of the Efficacy of Different Biologic Agents in Preventing Postoperative Endoscopic Recurrence of Crohn's Disease |
RECRUITING | |
| NCT07491913 |
Biologic Treatment Withdrawal in Takayasu Arteritis Patients in Sustained Remission |
RECRUITING | NA |
| NCT07398651 |
Apremilast and Adalimumab in Psoriatic Arthritis Patients |
NOT_YET_RECRUITING | NA |
| NCT07352566 |
Utilization of a Microdevice for Psoriasis and Atopic Dermatitis |
NOT_YET_RECRUITING | PHASE4 |
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Biologics in Folliculitis Decalvans : an Adaptative Trial Research |
NOT_YET_RECRUITING | PHASE2 |
| NCT07151937 |
A Study of LAD191 in Adults With Hidradenitis Suppurativa |
RECRUITING | PHASE2 |
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Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty |
RECRUITING | PHASE2 |
| NCT07113834 |
Characteristics of Ankylosing Spondylitis Associated Uveitis |
COMPLETED | |
| NCT07061574 |
A Randomized Phase 1/2 Trial of Low Dose Anti-thymocyte Globulin (ATG) With Subsequent Adalimumab or Verapamil in New Onset Type 1 Diabetes |
RECRUITING | PHASE1/PHASE2 |
| NCT07013838 |
The Efficacy and Safety of Deucravacitinib in Takayasu's Arteritis |
NOT_YET_RECRUITING | PHASE4 |
