The U.S. Food and Drug Administration has approved Immgolis and Immgolis Intri, the first biosimilar versions of golimumab therapies in the United States. These newly approved medications are expected to improve access to biologic treatments for adults living with rheumatoid arthritis and ulcerative colitis. The approval marks an important milestone in the biosimilar market and could help reduce treatment costs for patients who rely on advanced immune-modifying therapies.
Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals, announced the approval on May 18, 2026. The company plans to launch both products commercially in the fourth quarter of 2026.
Immgolis, known scientifically as golimumab-sldi, is a biosimilar to Simponi, while Immgolis Intri is a biosimilar to Simponi Aria. Both original drugs are widely used tumor necrosis factor blockers, also called TNF blockers, that help reduce inflammation caused by autoimmune diseases.
The FDA approved Immgolis for:
Immgolis Intri received approval for:
These approvals represent the first interchangeable biosimilars to golimumab therapies in the United States.
The approval of Immgolis and Immgolis Intri is significant because biosimilars often increase competition and improve affordability in the healthcare system. Many patients with chronic autoimmune diseases face high treatment costs for biologic medications. Introducing lower-cost biosimilar alternatives may improve patient access to long-term therapy.
According to Accord BioPharma President Chrys Kokino, the approval addresses a growing demand for more affordable treatment options for people living with rheumatoid arthritis and ulcerative colitis.
Biosimilars are designed to work nearly identically to existing biologic drugs, with no clinically meaningful differences in safety, purity, or effectiveness. The interchangeable designation from the FDA also means pharmacists may substitute the biosimilar for the reference product in certain cases, depending on state pharmacy laws.
Rheumatoid arthritis is a chronic autoimmune disease in which the immune system mistakenly attacks healthy joints. This can lead to pain, swelling, stiffness, and long-term joint damage. Moderate to severe cases often require biologic treatments to control inflammation and prevent disease progression.
Ulcerative colitis is another autoimmune condition that affects the digestive tract. It causes inflammation and ulcers in the colon and rectum, resulting in symptoms such as abdominal pain, diarrhea, fatigue, and weight loss.
TNF blockers like golimumab help reduce the inflammatory response that drives these diseases.
Many people confuse biosimilars with generic drugs, but they are not the same.
Generic drugs are exact chemical copies of brand-name medications. Biosimilars, on the other hand, are highly similar versions of biologic drugs that are made from living organisms. Because biologic medicines are complex, biosimilars cannot be exact copies. However, they must meet strict FDA standards to demonstrate similar safety and effectiveness.
The approval of interchangeable biosimilars such as Immgolis and Immgolis Intri is particularly important because it may simplify substitution and improve patient access at pharmacies and healthcare facilities.
Like the reference products Simponi and Simponi Aria, both Immgolis and Immgolis Intri carry boxed warnings for serious infections and malignancies.
Patients taking golimumab products face an increased risk of serious infections, including:
Healthcare providers are advised to test patients for latent tuberculosis before treatment begins. Patients should also be monitored carefully during therapy for signs of infection.
People over age 65, patients with other health conditions, and individuals taking immunosuppressive drugs such as corticosteroids or methotrexate may face greater infection risks.
The medications also carry warnings about lymphoma and other malignancies associated with TNF blockers. Some cases have occurred in children and adolescents receiving TNF-blocking therapies.
Doctors are encouraged to weigh the benefits and risks before starting treatment, particularly in patients with a history of cancer.
Other potential risks associated with Immgolis and Immgolis Intri include:
Patients should discuss all existing medical conditions and medications with their healthcare providers before starting therapy.
The most commonly reported side effects of Immgolis include:
For Immgolis Intri, common side effects include:
Not all patients experience side effects, but medical monitoring remains important during treatment.
Accord BioPharma stated that Immgolis and Immgolis Intri are expected to become available in the United States during the fourth quarter of 2026.
The company serves as the exclusive U.S. commercialization partner for both biosimilars, while Bio-Thera Solutions will continue handling manufacturing and supply operations.
This launch is part of Accord BioPharma’s larger biosimilar strategy, which aims to bring 20 biosimilars to the U.S. market by 2030.
Biosimilars have become increasingly important in modern healthcare because they help reduce spending on high-cost biologic medicines. Over the last several years, the FDA has approved numerous biosimilars across oncology, immunology, and inflammatory disease treatment categories.
As patents for biologic drugs expire, more biosimilar manufacturers are entering the market. Increased competition often leads to lower healthcare costs and wider patient access.
The approval of the first golimumab biosimilars adds another major autoimmune treatment option to the growing biosimilar landscape in the United States.
Patients considering Immgolis or Immgolis Intri should speak with a qualified healthcare professional to determine whether these therapies are appropriate for their condition.
Before beginning treatment, providers may:
Patients should promptly report symptoms such as fever, persistent cough, unexplained weight loss, skin changes, or unusual fatigue while receiving treatment.
Regular medical follow-up is important for monitoring treatment response and potential side effects.
The FDA approval of Immgolis and Immgolis Intri may encourage additional competition in the TNF inhibitor market. As more biosimilars become available, healthcare systems may benefit from improved pricing flexibility and broader treatment access.
Patients with rheumatoid arthritis and ulcerative colitis often require lifelong disease management. Expanded access to biologic therapies could improve treatment adherence and long-term outcomes for many individuals.
Industry experts expect biosimilars to remain a major focus in pharmaceutical development throughout the coming decade.
The FDA approval of Immgolis and Immgolis Intri represents an important development for patients living with rheumatoid arthritis and ulcerative colitis. As the first interchangeable golimumab biosimilars approved in the United States, these therapies could improve affordability and expand access to biologic treatment options.
While the medications offer promising benefits, patients and healthcare providers must carefully consider the potential risks associated with TNF blocker therapies, including serious infections and malignancies.
With commercial availability expected later in 2026, Immgolis and Immgolis Intri may soon become important alternatives within the growing biosimilar market.
This article is intended for informational and educational purposes only and should not be considered medical advice, diagnosis, or treatment guidance. Always consult a licensed healthcare provider before starting, stopping, or changing any medication or treatment plan. Information in this article may change as new clinical data and regulatory updates become available.
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