China-based Bio-Thera Pharmaceuticals (Bio-Thera) announced on 28 January 2021 that the US Food and Drug Administration (FDA) had accepted the Biologics License Application (BLA) for its proposed bevacizumab biosimilar, BAT1706.
Bevacizumab is a humanized monoclonal antibody. It inhibits angiogenesis (the formation of new blood vessels) by blocking the action of vascular endothelial growth factor A (VEGF-A). Bevacizumab can therefore slow the growth of new blood vessels in tumours and is used to treat various cancers, including colorectal, lung, breast, glioblastoma, kidney and ovarian.
The application is seeking approval of BAT1706 for the treatment of diseases for which the US-licensed originator biological Avastin (bevacizumab) is approved but excludes indications under orphan drug exclusivity protection.
Bio-Thera also had an application for approval of BAT1706 accepted by the European Medicines Agency (EMA) in December 2020 [1] and by China’s National Medical Products Administration (NMPA) in January 2020.
The BLA submission is based on data from a series of preclinical comparison studies, clinical pharmacokinetic comparison studies, and an international multicentre phase III clinical comparison study. Results from the phase III study [2], according to Bio-Thera, ‘demonstrated that BAT1706 is highly similar to reference bevacizumab in clinical efficacy, safety and immunogenicity’.
FDA has set a goal date for a decision on BAT1706 under the Biosimilar User Fee Act (BsUFA) of 27 November 2021.
BAT1706 is Bio-Thera’s second biological product. The company’s first product, Qletli (格乐立), a copy biological of Humira (adalimumab), received marketing authorization and launched in China in January 2020 [3]. The company is also developing proposed biosimilars of golimumab [2], mepolizumab, secukinumab, tocilizumab [2] and ustekinumab [4], among others.
Fellow China-based drugmaker Shanghai Henlius Biotech (Henlius) announced on 29 January 2021 that it had received approval from Australia’s Therapeutic Goods Administration (TGA) to start a two-part Phase III global clinical trial to evaluate the efficacy and safety of HLX04 in the treatment of wet age-related macular degeneration (wAMD). Henlius already has three copy biologicals, HLX01 (Hanlikon; rituximab), HLX02 (trastuzumab) and HLX03 (adalimumab) approved in China. While HLX02, which has the brand name Zercepac in Europe, was approved in Europe in July 2020, making it the first China-developed monoclonal antibody biosimilar to be approved in the region [5].
Editor’s comment
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 but they are not universally accepted by regulatory bodies outside of the European Union (EU). It should be noted that ‘copy biologicals’ approved in China might not have been authorized if they had been subjected to the strict regulatory processes required for approval of biosimilars in the EU.
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References
1. GaBI Online - Generics and Biosimilars Initiative. EMA accepts application for bevacizumab biosimilar BAT1706 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Feb 26]. Available from: www.gabionline.net/Biosimilars/News/EMA-accepts-application-for-bevacizumab-biosimilar-BAT1706
2. GaBI Online - Generics and Biosimilars Initiative. Positive results for Bio-Thera’s arthritis copy biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Feb 26]. Available from: www.gabionline.net/Biosimilars/Research/Positive-results-for-Bio-Thera-s-arthritis-copy-biologicals
3. GaBI Online - Generics and Biosimilars Initiative. Bio-Thera launches first adalimumab copy biological in China [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Feb 26]. Available from: www.gabionline.net/Biosimilars/News/Bio-Thera-launches-first-adalimumab-copy-biological-in-China
4. GaBI Online - Generics and Biosimilars Initiative. Bio-Thera gains Chinese approval for adalimumab copy biological and starts ustekinumab trial [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Feb 26]. Available from: www.gabionline.net/Biosimilars/News/Bio-Thera-gains-Chinese-approval-for-adalimumab-copy-biological-and-starts-ustekinumab-trial
5. GaBI Online - Generics and Biosimilars Initiative. EC approval for trastuzumab biosimilar Zercepac [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Feb 26]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-trastuzumab-biosimilar-Zercepac
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Source: Bio-Thera, Henlius
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