FDA Approves First Simponi Biosimilars in U.S.

Accord BioPharma Inc., the U.S. specialty division of Intas Pharmaceuticals, has 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), and 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.

Bio-Thera Solutions 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 U.S.

“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 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.”