Adalimumab is a human monoclonal antibody that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF); a soluble inflammatory cytokine. Adalimumab binds to TNF-alpha (TNF-α), preventing it from activating TNF receptors, which cause the inflammatory reactions associated with autoimmune diseases.

Qletli (格乐立) was developed by China-based Bio-Thera and the company announced in November 2019 that the product had been approved by China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), for all eligible indications of the reference biological, Humira (adalimumab) [1].

Bio-Thera announced in July 2019 that Qletli (BAT1406), had met its primary endpoint of equivalent efficacy to the reference product (AbbVie’s Humira) in a phase III trial in patients with ankylosing spondylitis [2]. Data from this trial, as well as analytical, non-clinical, pharmacokinetics, pharmacodynamics data were used to support the approval of Qletli in China.

Shengfeng Li, CEO of Bio-Thera, said that the ‘launch of Bio-Thera’s first approved product is an enormous milestone for the company’. He added that the company ‘is committed to bringing additional biosimilar and innovative products to the market in China and around the world’.

Bio-Thera is developing several proposed copy biologicals, including versions of Avastin (bevacizumab) [3] and Actemra/RoActemra (tocilizumab) [2], which are both currently being evaluated in global phase III clinical trials. The company is also pursuing copy biologicals of Humira (adalimumab) [2], Simponi (golimumab) [2] and Stelara (ustekinumab).

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.

Related article
Adalimumab copy biologicals accepted for review in China

References
1. 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 2020 Feb 21]. Available from: www.gabionline.net/Biosimilars/News/Bio-Thera-gains-Chinese-approval-for-adalimumab-copy-biological-and-starts-ustekinumab-trial
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 2020 Feb 21]. Available from: www.gabionline.net/Biosimilars/Research/Positive-results-for-Bio-Thera-s-arthritis-copy-biologicals
3. GaBI Online - Generics and Biosimilars Initiative. Positive phase I results for Bio-Thera’s bevacizumab copy biological [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Feb 21]. Available from: www.gabionline.net/Biosimilars/Research/Positive-phase-I-results-for-Bio-Thera-s-bevacizumab-copy-biological

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