Bio-Thera's Bevacizumab Shows High Similarity to Reference Avastin in PK, Safety, Immunogenicity

Bio-Thera Solutions, a global biotechnology company based in Guangzhou, China, has reported the results of a clinical study of its proposed bevacizumab biosimilar, BAT1706, referencing Avastin.

The study, a phase 1, randomized, double-blind, 3-arm study in 128 healthy adult male volunteers, was conducted to establish similarity between the proposed biosimlar and US-licensed and EU-licensed reference bevacizumab. Each of the volunteers was given a single intravenous infusion of 1 mg per kg of either the biosimilar or the US- or EU-licensed reference. The volunteers were then monitored for 14 week.

The primary pharmacokinetic (PK) end point of the study was area under the concentration curve from time zero to infinity (AUC_0—inf). Biosimilarity was determined if the 2-sided 90% CI ratios of the geometric means for the 3 comparisons were contained within the prespecified margin of 80% to 125%.

The study’s authors report that the PK parameters were comparable for the 3 products; the 90% CI for AUC_0—inf was 99% to 112% for the biosimilar versus the EU reference, 97% to 110% for the biosimilar versus the US reference, and 92% to 104% for the EU reference versus the US reference. Thus, biosimilarity was determined.

No significant adverse events related to the biosimilar were reported, and all 3 study drugs exhibited similar safety profiles. No anti-drug antibodies were reported for any of the volunteers in the study.

The authors concluded that the proposed biosimilar has high similarity to both EU- and US-licensed Avastin in terms of its demonstrated PK, safety, and immunogenicity in this study.

Bio-Thera has now advanced this proposed biosimilar to phase 3 development, and the company reports that its global phase 3 clinical trials are underway.

Earlier this year, Bio-Thera announced that it had entered into a licensing agreement with Cipla Limited concerning BAT1706; under the agreement, Bio-Thera is responsible for development, regulatory activities, and manufacturing of the product. Cipla will be responsible for sales and marketing in emerging markets.

Bio-Thera says that it intends to file BAT1706 for regulatory approval with the China National Medical Products Administration, the European Medicines Agency, and the FDA in 2020.

Reference

Wu X, Wynne C, Xu C, et al. A global phase 1 clinical study comparing the safety and pharmacokinetics of proposed biosimilar BAT1706 and bevacizumab (Avastin) in healthy male subjects [published online April 23]. BioDrugs. doi: 10.1007/s40259-019-00352-7.