Bio-Thera Solutions and Accord BioPharma have announced that the US Food and Drug Administration (FDA) has approved IMMGOLIS™ (golimumab-sldi) and IMMGOLIS INTRI™ (golimumab-sldi), the first biosimilars to Simponi® and Simponi Aria® in the United States.

IMMGOLIS, previously known as BAT2506, has been approved for the treatment of adults with moderately to severely active rheumatoid arthritis in combination with methotrexate, and for adults with moderately to severely active ulcerative colitis.

The FDA also approved IMMGOLIS INTRI for adults with moderately to severely active rheumatoid arthritis in combination with methotrexate.

Golimumab is a human IgG1 monoclonal antibody that targets tumour necrosis factor alpha (TNF-α), a molecule linked to inflammation. The treatment helps reduce several inflammatory markers associated with autoimmune diseases.

Bio-Thera and Intas Pharmaceuticals signed an exclusive commercialisation agreement in February 2025. Under the agreement, Bio-Thera is responsible for the development, manufacturing and supply of the products, while Accord BioPharma will manage commercialisation activities in the United States.

The companies stated that the approval strengthens their biosimilar portfolio and supports efforts to improve access to more affordable treatment options for patients with rheumatoid arthritis and ulcerative colitis.

IMMGOLIS is not approved for the treatment of psoriatic arthritis, ankylosing spondylitis, or paediatric ulcerative colitis patients weighing at least 15 kg.

IMMGOLIS INTRI is also not approved for psoriatic arthritis in patients aged two years and older, ankylosing spondylitis, or polyarticular juvenile idiopathic arthritis.

 

Source: prnewswire.com

Report Abuse