Bio-Thera Solutions Ltd. announced that it has reached a licensing agreement with Cipla Limited for BAT1706, its bevacizumab biosimilar, under which Cipla will have exclusive rights to distribute and market the drug in select emerging markets. BAT-1706 is a mAb biosimilar to Genentech's Avastin which is currently approved for six indications including metastatic colorectal cancer, recurrent glioblastoma and non-squamous non-small cell lung cancer. Bio-Thera's BAT-1706 is currently in a global Phase III study (NCT03329911) in patients with previously untreated advanced non-squamous non-small cell lung cancer.

Bio-Thera intends to file for regulatory approval with the China National Medical Products Administration (NMPA), the European Medicines Agency (EMA) and the United States Food and Drug Administration (USFDA) in 2020. This partnership will leverage Cipla's strong local presence, sales and marketing capabilities in the select emerging markets. Bio-Thera will be responsible for full development, product registration with the FDA and EMA, and commercial supply of BAT1706 out of its manufacturing facilities in Guangzhou, China.