Bio-Thera Solutions and Dr. Reddy's Laboratories 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. 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,” said Dr. Shengfeng Li, CEO of Bio-Thera.

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.