Accord BioPharma, the US specialty division of Intas Pharmaceuticals, has announced that the US Food and Drug Administration (FDA) has approved Immgolis (golimumab-sldi) and Immgolis Intri (golimumab-sldi), the first golimumab biosimilars approved in the United States.

Immgolis has been approved as a biosimilar to Simponi (golimumab) for the treatment of adult patients with moderately to severely active rheumatoid arthritis in combination with methotrexate, as well as adult patients with moderately to severely active ulcerative colitis. Meanwhile, Immgolis Intri, a biosimilar to Simponi Aria, has been approved for adults with moderately to severely active rheumatoid arthritis in combination with methotrexate.

The FDA has also designated both biosimilars as interchangeable for rheumatoid arthritis and ulcerative colitis indications, allowing pharmacists to substitute them for the reference biologics in accordance with state pharmacy regulations.

According to the company, the approvals mark the first time patients in the United States will have access to FDA-approved biosimilar alternatives for both Simponi and Simponi Aria, potentially improving affordability and expanding access to biologic therapies for autoimmune diseases.

Accord BioPharma said the products are expected to be commercially launched in the United States during the fourth quarter of 2026.

Chrys Kokino, president of Accord North America, stated that the approval represents a major milestone for patients suffering from chronic autoimmune conditions such as rheumatoid arthritis and ulcerative colitis, who often face high treatment costs. He added that the approvals support the company’s broader objective of bringing 20 biosimilars to market by 2030.

Binish Chudgar, Chairman and Managing Director of Intas Pharmaceuticals, said, “Biosimilars remain one of the most effective tools for improving affordability and accessibility within the US healthcare system. Accord BioPharma’s expertise and commercial capabilities position the company strongly to deliver the newly approved therapies to patients and healthcare providers.”

The biosimilars were developed by Bio-Thera Solutions, which will continue to oversee manufacturing and supply operations.

The companies clarified that Immgolis is not approved for use in patients with active psoriatic arthritis, ankylosing spondylitis or paediatric ulcerative colitis indications. Similarly, Immgolis Intri is not approved for active psoriatic arthritis in certain paediatric populations, ankylosing spondylitis or polyarticular juvenile idiopathic arthritis.

Accord BioPharma focuses on therapies in oncology, immunology and central nervous system disorders, while Bio-Thera Solutions is engaged in the development of innovative biologics and biosimilars for cancer, autoimmune and cardiovascular diseases, among other therapeutic areas.