Bio-Thera Solutions announced the company has reached a licensing agreement with Biomm S.A. for BAT1706, its bevacizumab biosimilar, under which Biomm will have exclusive rights to distribute and market the drug in Brazil. BAT1706 is a proposed bevacizumab biosimilar for the treatment of patients with metastatic colorectal cancer, metastatic or locally recurrent breast cancer, locally advanced, metastatic or recurrent non-small cell lung cancer, metastatic renal cell carcinoma, persistent, recurrent, or metastatic cervical cancer, and epithelial ovarian, fallopian tube, or primary peritoneal cancer. Bio-Thera's BAT1706 has successfully completed a global Phase III comparative clinical study which was a multicenter, randomized, double blind, study evaluating the efficacy, safety, pharmacokinetics and immunogenicity of BAT1706 versus EU-bevacizumab plus chemotherapy in patients with advanced non squamous non-small cell lung cancer.

Bio-Thera has filed the commercial license application for BAT1706 with the China National Medical Products Administration (NMPA) and also more recently with the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA). Biomm will be responsible for filing the dossier in Brazil. This partnership will leverage Biomm's strong local presence, sales and marketing capabilities in Brazil.

Bio-Thera will be responsible for full development, and commercial supply of BAT1706 out of its manufacturing facilities in Guangzhou, China.