Bio-Thera Solutions and Dr. Reddy’s Laboratories have signed an exclusive agreement to commercialise two proposed biosimilars, BAT2206 and BAT2506, in Southeast Asia.
The partnership assigns Bio-Thera the responsibility for the development, manufacturing, and supply of these biosimilars.
Dr. Reddy’s will manage regulatory approvals and commercial activities in countries including Cambodia, Indonesia, Malaysia, Thailand, the Philippines, and Vietnam.
Additionally, Dr. Reddy’s gains exclusive rights to commercialise BAT2206 in Colombia.
Bio-Thera CEO Shengfeng Li said: “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.
“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.”
BAT2206 is a proposed biosimilar to Stelara, a product developed by Janssen.
Stelara is a human monoclonal antibody that targets IL-12 and IL-23 proteins involved in inflammatory and immune response processes. It is used in treating autoimmune conditions such as moderate to severe plaque psoriasis, active psoriatic arthritis, Crohn’s disease, and ulcerative colitis.
The European Union (EU) has approved Stelara for patients with these conditions when they do not respond adequately to other treatments.
BAT2506 is another biosimilar under development by Bio-Thera as an alternative to Simponi, which is authorised for use in the US.
Simponi treats moderate to severe rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, and moderate to severely active ulcerative colitis. It includes a Boxed Warning due to risks of serious infection and malignancy associated with its use.
Dr. Reddy’s branded markets (India and emerging markets) CEO MV Ramana 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.”
