Positive phase III data for adalimumab copy biologicals Posted 02/08/2019

Positive phase III data for adalimumab copy biologicals has been presented at the European Congress of Rheumatology 2019 (EULAR 2019) [1].

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. Adalimumab is indicated for the treatment of rheumatoid, juvenile idiopathic and psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis and ulcerative colitis.

Hisun Pharma’s (Hisun) multicentre, randomized, double-blind, parallel-controlled, phase III study enrolled Chinese patients with ankylosing spondylitis (AS). The patients were randomly assigned to receive Hisun’s adalimumab copy biological HS016 (416) or originator adalimumab (232). The study evaluated the efficacy, pharmacokinetic (PK) equivalence, safety and immunogenicity of HS016 compared with adalimumab [1].

The authors concluded that ‘the results of efficacy, pharmacokinetics, safety, immunogenicity from the study conducted in Chinese AS patients support a high similarity between HS016 and [originator] adalimumab’.

In a second study, the adalimumab copy biological from China-based Bio‑Thera Solutions (Bio‑Thera) was evaluated in a multicentre, randomized, non-inferiority, double-blinded, controlled clinical trial. The study evaluated the safety and immunogenicity of BAT1406 versus originator adalimumab in patients with active AS. A total of 554 eligible patients were enrolled from Jan 2017 to Aug 2017 and were randomly assigned to receive BAT1406 (n = 363) or originator adalimumab (n = 191) [2].

The authors concluded that ‘the study met the primary endpoint of demonstrating equivalent efficacy of BAT1406 and [originator adalimumab]. BAT1406 was comparable in tolerance, safety and immunogenicity with [originator adalimumab] in active AS patients’.

These results were presented at the European Congress of Rheumatology 2019, which took place on 12–15 June 2019 in Madrid, Spain.

Both of these copy biologicals were accepted for review by the China Food and Drug Administration in 2018 [3].

Conflict of interest
The authors of the abstracts [1, 2] reported conflict of interest, including being employees of pharmaceutical companies. For full details of the authors’ conflict of interest, see the abstracts [1, 2].

Editor’s comment
It should be noted that data of the study presented in this article was published as an abstract and presented at a conference. These data and conclusions should be considered as preliminary until published in a peer-reviewed journal.

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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1. Su J, Mengtao L, Zeng X. FRI0413 (2019): Efficacy, pharmacokinetics, safety and immunogenicity of the biosimilar HS016 in comparison with adalimumab in chinese patients with ankylosing spondylitis: a multicenter, randomized, double-blind, parallel-group, phase 3 trial. European Congress of Rheumatology 2019; 2019 Jun 12−15;Madrid, Spain.
2. Tu L, Wei Q, Xie Y, et al. FRI0415 (2019): Biosimilar BAT1406 versus adalimumab therapy on active ankylosing spondylitis: a randomized, double-blinded, multicenter, controlled phase 3 trial. European Congress of Rheumatology 2019; 2019 Jun 12−15;Madrid, Spain.
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 Aug 2]. Available from: www.gabionline.net/Biosimilars/News/Adalimumab-copy-biologicals-accepted-for-review-in-China 

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