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Dr. Reddy’s and Bio-Thera Solutions have entered into exclusive commercialization and license agreements for two proposed biosimilars—BAT2206 (ustekinumab) and BAT2506 (golimumab)—targeting Southeast Asian markets, with Dr. Reddy’s also securing exclusive rights to BAT2206 in Colombia.
As per the notification published on 26 March 2025, Dr. Reddy’s Laboratories Ltd., a global pharmaceutical leader based in India, has entered into a strategic commercialization and licensing agreement with China-based biopharmaceutical company Bio-Thera Solutions. This collaboration aims to introduce two advanced biosimilar products—BAT2206 and BAT2506—in multiple emerging markets across Southeast Asia, as well as Colombia.
Under the terms of the agreement, Bio-Thera Solutions will continue to be responsible for the research, development, manufacturing, and supply of these biosimilars, while Dr. Reddy’s will take charge of regulatory filings, approvals, and commercialization activities in Cambodia, Indonesia, Malaysia, the Philippines, Thailand, and Vietnam. Additionally, Dr. Reddy’s has secured exclusive rights to market BAT2206 in Colombia, further expanding its footprint in Latin America.
About the Biosimilars
BAT2206 is a biosimilar candidate referencing ustekinumab, a monoclonal antibody that selectively blocks the pro-inflammatory cytokines interleukin-12 and interleukin-23 (IL-12/IL-23). It is widely prescribed for immune-mediated inflammatory diseases such as ulcerative colitis, Crohn’s disease, psoriatic arthritis, and plaque psoriasis. The biosimilar BAT2206 has completed global Phase III clinical trials, illustrating comparable efficacy, safety, and immunogenicity to the reference product.
BAT2506 is being developed as a biosimilar to golimumab, another monoclonal antibody targeting tumor necrosis factor-alpha (TNF-α), a primary mediator of inflammation in autoimmune ailments. It is advocated for moderate-to-severe rheumatoid arthritis, ulcerative colitis, active psoriatic arthritis, and ankylosing spondylitis. BAT2506 is advancing through clinical development with the goal of offering an affordable alternative to the originator biologic.
Strategic Importance of the Partnership
Dr. Reddy’s brings extensive expertise and a strong commercial presence in emerging markets, making it a natural partner to bring Bio-Thera’s biosimilars to patients who currently face limited access owing to the high cost of biologic therapies. By combining Bio-Thera’s innovative development capabilities with Dr. Reddy’s regulatory and commercial strengths, the partnership aims to expedite patient access to these important treatment options.
Broader Impact
The introduction of these biosimilars is anticipated to enhance treatment options and curtail healthcare costs in countries where access to biologics remains limited. These therapies have the potential to boost outcomes for those suffering from debilitating autoimmune and inflammatory conditions, including psoriasis, rheumatoid arthritis, Crohn’s disease, and ulcerative colitis.
As biologics constitute a rapidly growing segment in the pharmaceutical market, expanding biosimilar availability supports global health initiatives aimed at strengthening equity and affordability in healthcare.
Dr Reddy's Press Release
Bio-Thera and Dr. Reddy’s Execute Exclusive Commercialization Agreement for BAT2206, a Proposed Stelara® Biosimilar, and BAT2506, a Proposed Simponi® Biosimilar, for Southeast Asia
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