Hyderabad: Dr. Reddy’s Labs said Wednesday that his subsidiary, Dr. Reddy’s Labs SA, has held marketing and license agreements with China’s Bio-Sthera solutions for Biosimilar of two of the human monoclonal antibodies (MABS) of Janssen – Star (Ustekinumab) and Simponi (Golimumab) – For the markets of Southeast Asia.
Although Bat2206 of Bio-Sthera is a proposed biosimilar of Stelara, Bat2506 is a proposed biosimilar of Simponi developed by Bio-Sthera, a biopharmaceutical company in commercial stage that is developing a pipe of innovative and biosimilar therapies.
As part of the agreement, Bio-Thera will develop, manufacture and supply Bat2206 and Bat2506, while Dr. Reddy will be responsible for seeking regulatory approvals and marketing these two biosimilar in license territories in Southeast Asia that include Cambodia, Indonesia, Malaysia, Philippines, Thailandand and Vietnam.
Dr. Reddy’s, based in Hyderabad, said it will also obtain exclusive commercial rights to market Bat2206 in Colombia as part of the agreement.
Bat2206 inhibits the bioactivity of human IL-12 and IL-23, which are involved in inflammatory and immune responses, such as the activation of natural murderous cells and the differentiation and activation of CD4+cells. It prevents P40 from sharing to join the protein of the IL-12Rß1 receptor expressed on the surface of the immune cells.
Stelara has been approved for the treatment of moderate to severe plaque psoriasis in adults and children aged for six years, active psoriatic arthritis in adults, moderately to Crohn’s disease severely active in adults and moderately to severely active ulcerative colitis in adults.
Simponi, which inhibits the biological activity of the Alfa Tumor necrosis factor (TNF-ALFA), has been approved in the US.
Dr. Reddy’s CEO for brand markets (India and emerging markets) MV Ramana said the association would allow the company to further expand its biosimilar offers in emerging markets.
“With our well -established commercial strengths in these markets, we hope to address the unattered needs of patients with access to affordable medications,” he said.
The CEO of the bio-thera, Dr. Shengfeng Li, said that the association with Dr. Reddy’s is the first agreement of the company that will focus solely on Southeast Asia.
“Dr. Reddy’s is the perfect partner to help bring Bat2206 and Bat2506 to patients in the region. This collaboration with Dr. Reddy’s demonstrates our commitment to patients in Southeast Asia,” Li said.