GUANGZHOU, China, May 18, 2026 /PRNewswire/ -- Bio-Thera Solutions (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, and Accord BioPharma, Inc, the U.S. specialty division of Intas Pharmaceuticals, Ltd. ("Intas"), focused on the development of oncology, immunology and central nervous system (CNS) therapies, today announced Accord BioPharma received marketing authorization in the United States of America for IMMGOLIS (formerly known as BAT2506), a SIMPONI^® (golimumab) biosimilar, for the treatment of adults patients with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate, and for the treatment of adult patients with moderately to severely active ulcerative colitis (UC). The FDA also approved IMMGOLIS INTRI (golimumab-sldi), a biosimilar to Simponi Aria® (golimumab), for the treatment of adult patients with moderately to severely active RA in combination with methotrexate. IMMGOLIS™ (golimumab-sldi) and IMMGOLIS INTRI™ (golimumab-sldi) are the first FDA approved biosimilars to Simponi^® (golimumab) and Simponi Aria^® (golimumab) for rheumatoid arthritis in combination with methotrexate and for ulcerative colitis.

Golimumab is a human IgG1 monoclonal antibody that targets tumor necrosis factor alpha (TNF-α), a pro-inflammatory molecule. Binding of golimumab to TNF-α results in reductions in C-reactive protein (CRP), Interleukin 6 (IL-6), Intercellular Adhesion Molecule 1 (ICAM-1), Matrix Metalloproteinase 3 (MMP-3), and Vascular Endothelial Growth Factor (VEGF), all inflammatory markers. 

Bio-Thera signed an exclusive commercialization agreement with Intas on February 10, 2025.  Under the agreement, Bio-Thera is responsible for development, manufacturing, and supply of IMMGOLIS and IMMGOLIS INTRI.  Accord BioPharma will be responsible for commercializing IMMGOLIS and IMMGOLIS INTRI in the United States of America.

"Bio-Thera is proud to have developed the first approved biosimilar of golimumab in the United States of America", said Dr. Shengfeng Li, CEO of Bio-Thera. "We are excited to support Accord BioPharma's commercialization efforts to bring I IMMGOLIS and IMMGOLIS INTRI to patients in need of an affordable biosimilar of golimumab who are living with the chronic, debilitating autoimmune conditions associated with moderately to severely active rheumatoid arthritis or ulcerative colitis."

"Our exclusive commercialization agreement with Bio-Thera strengthens our biosimilar pipeline, a vital component of our U.S. growth strategy," said Chrys Kokino, President, North America of Accord. "We're investing heavily in biosimilars through external partnerships plus our own clinical efforts, because we believe in their vast potential to drive patient- and provider-centric solutions. Bio-Thera's global experience makes them an excellent partner."

IMMGOLIS is not indicated for and should not be used or administered for the treatment of adult patients with active psoriatic arthritis (PsA) alone, or in combination with methotrexate; adult patients with active ankylosing spondylitis (AS); or pediatric patients weighing at least 15 kg with moderately to severely active ulcerative colitis (UC).

IMMGOLIS INTRI is not indicated for and should not be used or administered for the treatment of Active Psoriatic Arthritis (PsA) in patients 2 years of age and older; Adult patients with active Ankylosing Spondylitis (AS); or Active polyarticular Juvenile Idiopathic Arthritis (pJIA) in patients 2 years of age and older.

About Bio-Thera Solutions
Bio-Thera Solutions, Ltd., a leading innovative, global biopharmaceutical company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular, eye diseases, and other severe unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases. As a leader in next generation antibody discovery and engineering, the company has advanced multiple candidates into late-stage development, including six approved products: QLETLI^® (adalimumab) and BETAGRIN^® (bevifibatide citrate) Injection in China, STARJEMZA^® (ustekinumab) in the US and USYMRO^® (ustekinumab) in EU, IMMGOLIS^TM and IMMGOLIS INTRI^TM (golimumab) in US and GOTENFIA^® (golimumab) in EU, TOFIDENCE® (tocilizumab) in the US, and AVZIVI^® (bevacizumab-tnjn) in the US and in EU, a/k/a POBEVCY^® in China. In addition, the company has more than 20 promising candidates in clinical trials, focusing on immuno-oncology in the post-PD-1 era and targeted therapies such as antibody-drug conjugates (ADCs). For more information, please visit www.bio-thera.com/en/ or follow us on X (@bio_thera_sol) and WeChat (Bio-Thera).

About Intas Pharmaceuticals
Intas Pharmaceuticals Ltd. is a leading vertically integrated pharmaceutical company headquartered in Ahmedabad, India, with group revenues of USD 2.6 billion. Intas has end-to-end capabilities across formulation development, manufacturing and marketing, including API integration, and strong in-house biosimilar capabilities with more than 15 marketed products. The company operates in 85 countries and employs over 22,000 people. For more information, visit www.intaspharma.com

About Accord BioPharma, Inc.
Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, seeks to provide affordable, accessible, patient-centric therapies in oncology, immunology, and critical care. With a focus on improving the patient experience, Accord BioPharma goes beyond the biology of medicine to see disease from the patients' perspective and develop high-quality therapies that impact patients' lives. Accord BioPharma believes in the ability of biosimilars to increase access to a number of biologic medicines, that in the past may not have been considered for patients due to their high costs. Accord BioPharma looks forward to providing one of the deepest biosimilar portfolios in the industry. For more information, visit AccordBioPharma.com.

Bio-Thera Cautionary Note Regarding Forward-Looking Statements
This news release contains certain forward-looking statements relating to IMMGOLIS and IMMGOLIS INTRI (aka BAT2506), or the product pipelines in general of Bio-Thera Solutions. Readers are strongly cautioned that reliance on any forward-looking statements involves known and unknown risks and uncertainties. The forward-looking statements include, among others, those containing "could," "may," "should," "will," "would," "anticipate," "believe," "plan," "promising," "potentially," or similar expressions. They reflect the company's current views with respect to future events that are based on what the company believes are reasonable assumptions in view of information currently available to Bio-Thera Solutions, and are not a guarantee of future performance or developments. Actual results and events may differ materially from information contained in the forward-looking statements as a result of a number of factors, including, but not limited to, risks and uncertainties inherent in pharmaceutical research and development, such as the uncertainties of pre-clinical and clinical studies. Other risks and uncertainties include challenges in obtaining regulatory approvals, manufacturing, marketing, competition, intellectual property, product efficacy or safety, changes in global healthcare situation, changes in the company's financial conditions, and changes to applicable laws and regulations, etc. Forward-looking statements contained herein are made only as of the date of their initial publication. Unless required by laws or regulations, Bio-Thera Solutions undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, changes in the company's views or otherwise.

1. SIMPONI^® is a registered trademark of Johnson & Johnson
2. SIMPONI ARIA^® is a registered trademark of Johnson & Johnson
3. IMMGOLIS^TM is a trademark of Accord Biopharma, Inc.
4. IMMGOLIS INTRI^TM is a trademark of Accord Biopharma, Inc.
5. QLETLI^® is a registered trademark of Bio-Thera Solutions, Ltd.
6. BETAGRIN^® is a registered trademark of Bio-Thera Solutions, Ltd.
7. STARJEMZA® is a registered trademark of Hikma
8. USYMRO^® is a registered trademark of Gedeon Richter
9. GOTENFIA^® is a registerd trademark of STADA Arzneimittel AG
10. TOFIDENCE^TM is a trademark of N.V. ORGANON
11. AVZIVI^® is a registered trademark of Sandoz AG
12. POBEVCY^® is a registered trademark of Bio-Thera Solutions, Ltd.

Contact
Bert E. Thomas IV
Phone: +1.410.627.1734
Email: bethomas@bio-thera.com

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