HYDERABAD: Dr Reddy’s Labs on Wednesday said its subsidiary, Dr Reddy’s Labs SA, has entered into commercialisation and licencing agreements with China’s Bio-Thera Solutions for biosimilars of two of Janssen’s human monoclonal antibodies (mABs) – Stelara (Ustekinumab) and Simponi (Golimumab) – for the South East Asian markets. While Bio-Thera’s BAT2206 is a proposed biosimilar of Stelara, BAT2506 is a proposed biosimilar of Simponi developed by Bio-Thera, a commercial-stage biopharmaceutical company that is developing a pipeline of innovative therapies and biosimilars. As part of the agreement, Bio-Thera will develop, manufacture and supply BAT2206 and BAT2506, while Dr Reddy’s will be responsible for seeking regulatory approvals and commercialise these two biosimilars in licensed territories in Southeast Asia that include Cambodia, Indonesia, Malaysia, Philippines, Thailand and Vietnam.
Hyderabad-based Dr Reddy’s said it will also get exclusive commercial rights to market BAT2206 in Colombia as part of the deal. BAT2206 inhibits the bioactivity of human IL-12 and IL-23, both of which are involved in inflammatory and immune responses such as natural killer cell activation and CD4+ T-cell differentiation and activation. It prevents shared p40 from binding to the IL-12Rß1 receptor protein expressed on the surface of immune cells.
Stelara has been approved for the treatment of moderate to severe plaque psoriasis in adults and children aged over six years, acti.