FDA Approves IMMGOLIS and IMMGOLIS INTRI, First Golimumab Biosimilars to Simponi for RA and Ulcerative Colitis

FDA Approves IMMGOLIS™ (golimumab-sldi) and IMMGOLIS INTRI™ (golimumab-sldi), First Biosimilars to Simponi® (golimumab) and Simponi Aria® (golimumab); Accord BioPharma to Lead U.S. Commercialization

Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd. focused on the development of oncology, immunology and central nervous system therapies, announced that the U.S. Food and Drug Administration (FDA) has approved IMMGOLIS, a biosimilar to Simponi, for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate, and adult patients with moderately to severely active ulcerative colitis (UC).

President of Accord North America, Chrys Kokino, stated that 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.

According to Towards Healthcare, the North America Intravenous Solutions Market is projected to experience significant growth, with estimates suggesting the market size will increase from USD 6.26 billion in 2026 to approximately USD 11.7 billion by 2035, representing a compound annual growth rate (CAGR) of 7.2% from 2026 to 2035. Growth is due to an increasing demand for critical care nutritional support with rising preference for outpatient infusion services and long-term parenteral nutrition. The market is growing strongly due to advanced medical infrastructure, high surgical volumes, and a shift toward home healthcare.

About Accord BioPharma

The company focuses on improving the patient experience. According to BioPharma, it goes beyond the biology of medicine to see disease from the patients' perspective and develop high-quality therapies that impact patients' lives. 
It announced the commercial launch of these products and the Boxed Warning for OSVYRTI. The company is advancing an ambitious pipeline to bring 20 biosimilars to the U.S. market by 2030.

About Bio-Thera Solutions

Bio-Thera focuses entirely on researching and manufacturing novel therapeutics and biosimilars for cancer, autoimmune diseases, cardiovascular conditions, and eye diseases. Their role in the North American pharmaceutical market relies on developing these medicines and licensing them to regional partners for commercialization. 
Growth is fueled by increasing surgical volumes and the expanding demand for home-based critical care and parenteral nutrition.

A recent report by Towards Healthcare highlights that the North America Intravenous Solutions Market is witnessing growth driven by rising cases of malnutrition or gastrointestinal disorders, which are driving significant demand for these specialized nutritional infusions, reducing inpatient costs, and expanding personalized care. The home-use segment has emerged as the leading end-use category.