FDA Approves ImmGolis for Accord BioPharma: First Interchangeable Simponi Biosimilar Enters U.S. Market

FDA Approves ImmGolis (golimumab-sldi) and ImmGolis Intri (golimumab-sldi), marking the inaugural arrival of biosimilar alternatives to the widely used reference biologics Simponi and Simponi Aria. Developed by Bio-Thera Solutions and to be commercialized in the United States by Accord BioPharma, these medications represent a critical expansion in the treatment options for patients managing chronic autoimmune conditions. The dual approval covers both subcutaneous and intravenous formulations, providing flexible administration routes for healthcare providers and patients alike.

The designation of ImmGolis as an interchangeable simponi biosimilar marks a pivotal shift in the immunology landscape. Under FDA interchangeability standards, this status allows pharmacists to substitute the biosimilar for the reference product without a new prescription from the healthcare provider, depending on individual state laws. This streamlined process is expected to significantly lower the financial barriers for patients managing long-term conditions like rheumatoid arthritis (RA) and ulcerative colitis (UC).

Clinical Indications and The Role of the Simponi Biosimilar

ImmGolis is currently indicated for adults with moderately to severely active RA (in combination with methotrexate) and for adults with moderately to severely active UC. Its intravenous counterpart, ImmGolis Intri, is approved specifically for adults with RA when used with methotrexate. While the reference products carry additional indications for psoriatic arthritis and ankylosing spondylitis, the initial rollout of this simponi biosimilar focuses on these high-impact areas to ensure rapid market entry and patient support.

The partnership between Accord BioPharma and Bio-Thera Solutions highlights a strategic move to stabilize the U.S. supply of critical biologics. Accord BioPharma, a leader in specialty pharmaceuticals, is leveraging this approval to advance its “20 by 2030” initiative, which aims to bring twenty biosimilars to the American market by the end of the decade. By introducing a high-quality simponi biosimilar, the company is addressing a significant unmet need for cost-effective TNF-alpha inhibitors.

Learn More

Pfizer Inc. Announces Milestone as FDA Approves Pfizer’s Ibrance Regimen for Advanced Breast Cancer Frontline Maintenance

As the first golimumab biosimilars approved in the U.S., IMMGOLIS and IMMGOLIS INTRI represent a meaningful new option for people in the U.S. who are living with the chronic, debilitating autoimmune conditions associated with moderately to severely active rheumatoid arthritis or ulcerative colitis and need more affordable medication,

Advertisement

This approval answers a clear demand in the U.S. market and helps advance our ambitious goal to bring 20 biosimilars to market by the year 2030.

JobFinder Listing

Quality Specialist – Thermo Fisher Scientific Jul 17, 2026 HSE Specialist – Novartis Jul 16, 2026 Field Application Specialist – Sartorius Jul 14, 2026 Regulatory Professional – Novo Nordisk Jul 12, 2026 Senior Biotechnologist – Sanofi Jul 10, 2026

Chrys Kokino, President of Accord North America.

Safety Standards and Monitoring for ImmGolis

Safety remains a top priority, and the FDA has mandated that every simponi biosimilar carries the same boxed warnings as its reference product. These warnings highlight risks of serious infections, including tuberculosis and invasive fungal infections, and potential malignancies like lymphoma. Patients are encouraged to review the official medication guide and maintain regular screenings with their healthcare team during the course of treatment.

Manufacturing for these products takes place at Bio-Thera Solutions’ state-of-the-art facilities in Guangzhou, China. The “totality of evidence” reviewed by the FDA confirmed that there are no clinically meaningful differences in safety, purity, or potency between ImmGolis and the original golimumab.

Learn More

LIPFENDRA FDA Approval: Merck’s Enlicitide Becomes First Oral PCSK9 Inhibitor to Lower LDL-C

Regulatory and Manufacturing Overview

Clinical Indications Comparison

Administration and Packaging