Dr Reddy's Labs, Bio-Thera collaborate for proposed Stelara, Simponi biosimilar

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2025-03-27T14:30:55+05:30 | Updated On 27 March 2025 2:30 PM IST

Hyderabad: Dr Reddy's Laboratories SA, wholly-owned subsidiary of Dr Reddy's Laboratories Ltd. and Bio-Thera Solutions, a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, have announced that they have reached commercialization and license agreements for BAT2206, a Proposed Stelara Biosimilar, and BAT2506, a Proposed Simponi Biosimilar.

Under the agreement, Bio-Thera will maintain responsibility for development, manufacturing, and supply of BAT2206 and BAT2506.

Dr. Reddy’s will be responsible for seeking regulatory approvals as well as commercialization in the licensed territories in Southeast Asia, including Cambodia, Indonesia, Malaysia, Philippines, Thailand, Vietnam. In addition, Dr. Reddy’s will also receive the exclusive commercial rights to BAT2206 in Colombia.

“This is our first partnership focused solely on Southeast Asia and Dr. Reddy’s is the perfect partner to help bring BAT2206 and BAT2506 to patients in the region”, said Dr. Shengfeng Li, CEO of Bio-Thera. “Bio-Thera believes in the health and welfare of patients around the world and this collaboration with Dr. Reddy’s demonstrates our commitment to the patients in Southeast Asia.”

M.V. Ramana, CEO – Branded Markets (India & Emerging Markets), Dr. Reddy’s, said, “Our partnership with Bio-Thera enables us to further expand our biosimilars offerings in the emerging markets. With our well-established commercial strengths in these markets, we look forward to addressing the unmet needs of patients with access to affordable medicines.”

BAT2206 is a proposed biosimilar to Jansen’s Stelara which is a human monoclonal antibody that inhibits the bioactivity of human IL-12 and IL-23 by preventing shared p40 from binding to the IL-12Rβ1 receptor protein expressed on the surface of immune cells. IL-12 and IL-23 are involved in inflammatory and immune responses, such as natural killer cell activation and CD4+ T-cell differentiation and activation. IL-12 and IL-23 have been implicated as important contributors to the chronic inflammation that is a hallmark of Crohn's disease and ulcerative colitis, among many other autoimmune diseases. In the EU, Stelara is currently approved for the treatment of 1) moderate to severe plaque psoriasis in adults and children above the age of 6 years whose condition has not improved with, or who cannot use, other systemic (whole-body) psoriasis treatments, 2) active psoriatic arthritis, alone or combined with methotrexate, in adults, when the condition has not improved enough with other treatments called disease-modifying anti-rheumatic drugs (DMARDs), 3) moderately to severely active Crohn’s disease in adults whose condition has not improved enough with other treatments for Crohn’s disease or who cannot receive such treatments, 4) moderately to severely active ulcerative colitis in adults whose condition has not improved enough with other treatments for ulcerative colitis or who cannot receive such treatments.

BAT2506 is a proposed golimumab biosimilar developed by Bio-Thera. Golimumab, a human monoclonal antibody, inhibits the biological activity of tumor necrosis factor alpha (TNF-alpha). Originator product Simponi is approved in the U.S. for moderate to severe rheumatoid arthritis; active psoriatic arthritis; active ankylosing spondylitis and moderate to severely active UC, and carries a Boxed Warning for Serious Infection and Malignancy.

bio thera solutionsdr reddys labsBAT2206stelarasimponiBAT2506

Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751