China-based Bio‑Thera Solutions (Bio‑Thera) has published phase I results for its candidate bevacizumab copy biological, BAT1706 [1].
The phase I clinical trial (NCT03030430) was a randomized, double-blind, 3-arm study in which 128 healthy adult male volunteers received a single IV infusion of 1 mg/kg of study drug and were subsequently monitored for 14 weeks. The aim of the trial was to study the pharmacokinetics (PKs), safety and immunogenicity of BAT1706 compared to US-licensed (US-BEV) and EU-licensed (EU-BEV) originator bevacizumab (Roche’s Avastin).
The primary PK endpoint of the study was area under the concentration curve from time zero to infinity (AUC0–inf). Biosimilarity was confirmed if the two-sided 90% confidence interval (CI) ratios of the geometric means for the three pairwise comparisons were contained within the prespecified margin of 80%–125%.
The results, according to the authors, showed that the PK parameters were comparable for the three drug products evaluated. The 90% CI for the AUC0–inf was 99%–112% for BAT1706 versus EU-BEV, 97%–110% for BAT1706 vs US-BEV and 92%–104% for EU-BEV versus US-BEV comparisons, respectively, demonstrating biosimilarity.
There were no significant adverse events attributable to BAT1706, as compared to EU-BEV and US-BEV. BAT1706 demonstrated a similar safety profile to EU-BEV and US-BEV. In addition, no anti-drug antibody positive result was reported for any subject included in the study. No significant adverse events related to the biosimilar were reported, and all three study drugs exhibited similar safety profiles. No anti-drug antibodies were reported for any of the volunteers in the study.
The authors concluded that BAT1706 ‘was shown to be highly similar to EU-BEV and US-BEV in terms of pharmacokinetic equivalence, safety, and immunogenicity in healthy subjects after a single IV infusion’.
Bio-Thera signed a licensing agreement for BAT1706 in January 2019 with India-based Cipla and is currently carrying out a global phase III study (NCT03329911) in patients with previously untreated advanced non-squamous non-small cell lung cancer. The company says that it intends to file for regulatory approval with China’s National Medical Products Administration (NMPA), the European Medicines Agency and the US Food and Drug Administration in 2020 [2].
Bio-Thera has also started a global phase III trial for its tocilizumab copy biological, BAT1806, and reported that the Biologics License Application (BLA) for its adalimumab copy biological, BAT1406 was accepted for review by China’s National Medical Products Administration in August 2018 [3]. The company is also pursuing copy biologicals of ustekinumab, secukinumab and golimumab [2].
Conflict of interest
The authors of the research paper [1] reported conflicts of interest, including being employees of Bio-Thera Solutions. For full details of the authors’ conflict of interest, see the research paper [1].
Editor’s comment
It should be noted that ‘copy biologicals’ approved in China might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the European Union. The EMA (European Medicines Agency) regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product.
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References
1. Wu, X., Wynne, C., Xu, C. et al. A Global Phase I Clinical Study Comparing the Safety and Pharmacokinetics of Proposed Biosimilar BAT1706 and Bevacizumab (Avastin®) in Healthy Male Subjects. BioDrugs 2019. doi:10.1007/s40259-019-00352-7
2. GaBI Online - Generics and Biosimilars Initiative. Bio-Thera advances bevacizumab and tocilizumab copy biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jun 21]. Available from: www.gabionline.net/Biosimilars/News/Bio-Thera-advances-bevacizumab-and-tocilizumab-copy-biologicals
3. GaBI Online - Generics and Biosimilars Initiative. Adalimumab copy biologicals accepted for review in China [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jun 21]. Available from: www.gabionline.net/Biosimilars/News/Adalimumab-copy-biologicals-accepted-for-review-in-China
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