Bio-Thera Solutions, a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, and Dr. Reddy’s Laboratories SA, wholly-owned subsidiary of Dr. Reddy’s Laboratories, announce they have reached commercialisation and license agreements for BAT2206, a proposed Stelara Biosimilar, and BAT2506, a proposed Simponi Biosimilar.
Under the agreement, Bio-Thera will maintain responsibility for the development, manufacturing, and supply of BAT2206 and BAT2506. Dr. Reddy’s will be responsible for seeking regulatory approvals as well as commercialisation in the licensed territories in Southeast Asia, including Cambodia, Indonesia, Malaysia, Philippines, Thailand, and Vietnam. In addition, Dr. Reddy’s will also receive the exclusive commercial rights to BAT2206 in Colombia.
About BAT2206 (ustekinumab)
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.
About BAT2506 (golimumab)
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). The 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.