Dr Reddy's inks South East Asia commercialisation, licence pacts with China's Bio-Thera for Stelara, Simponi biosimilars

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, active psoriatic arthritis in adults, moderately to severely active Crohn’s disease in adults and moderately to severely active ulcerative colitis in adults.
Simponi, which inhibits the biological activity of tumour necrosis factor alpha (TNF-alpha), has been approved in the US for those suffering from moderate to severe rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis and moderate to severely active UC.
Dr Reddy’s CEO for branded markets (India & emerging markets) MV Ramana said the partnership would enable the company to further expand its biosimilars offerings in 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,” he said.
Bio-Thera CEO Dr Shengfeng Li said the partnership with Dr Reddy’s is the company’s first deal to be focussed 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 the patients in Southeast Asia,” Li said.