Dr Reddy’s inks exclusive commercialisation pact on biosimilars for Southeast Asia

Bio-Thera Solutions, a commercial-stage biopharmaceutical company developing a pipeline of biosimilars, and Dr Reddy’s Laboratories SA, a wholly-owned subsidiary of Dr Reddy’s Laboratories, have entered into commercialisation and license agreements for BAT2206, a proposed Stelara biosimilar, and BAT2506, a proposed Simponi biosimilar.

Under the agreement, Chinese drug maker Bio-Thera will maintain responsibility for developing, manufacturing, and supplying BAT2206 and BAT2506. Hyderabad-based Dr Reddy’s will seek regulatory approvals and commercialisation in the licensed territories in Southeast Asia, including Cambodia, Indonesia, Malaysia, the Philippines, Thailand, and 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”, Shengfeng Li, CEO of Bio-Thera, said in a release on Wednesday.

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 chronic inflammation, 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 moderate to severe plaque psoriasis in adults and children over six who have not improved with or cannot use other systemic (whole-body) psoriasis treatments.

It is also approved for active psoriatic arthritis, alone or combined with methotrexate, in adults when the condition has not improved enough with other treatments, such as disease-modifying anti-rheumatic drugs. 

BAT2506 is a proposed golimumab biosimilar developed by Bio-Thera. Golimumab, a human monoclonal antibody, inhibits the biological activity of tumour 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 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.