Adalimumab copy biologicals accepted for review in China

Biosimilars/News | Posted 28/09/2018 post-comment0 Post your comment

China Food and Drug Administration (CFDA) has accepted applications for approval of adalimumab copy biologicals from Hisun Pharma (Hisun) and Bio‑Thera Solutions (Bio‑Thera).


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.

On 15 September 2018, Hisun announced that its proposed adalimumab copy biological had been accepted for review by CFDA.

Hisun says that the drug was developed based on the Chinese Technical Guidelines for copy biologicals, which was updated and finalized for release in early 2015 [1]. The submission is based on comprehensive data package that includes comparability studies, including analytical, preclinical and clinical trials including pharmacokinetics, efficacy and safety. Hisun states that immunogenicity and other comparative studies, ‘are highly similar to the originator drug Humira’.

Bio-Thera announced on 24 August 2018 that its proposed adalimumab copy biological BAT1406 had been accepted for review by CFDA. Bio-Thera’s product is a copy biological of AbbVie’s Humira (adalimumab), which is used to treat patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, chronic psoriasis, hidradenitis suppurativa, and juvenile idiopathic arthritis.

Bio-Thera says that the Biologics License Application (BLA) for BAT1406 ‘is the first BLA for a proposed adalimumab biosimilar accepted for review in China’. They add that they ‘expect BAT1406 to be the first Humira biosimilar to be approved for the China market’.

The BLA for BAT1406 consists of a comprehensive data package that includes analytical, preclinical and clinical data. Clinical studies included a pharmacokinetic/pharmacodynamic (PK/PD) trial, and a phase III confirmatory safety and efficacy study in ankylosing spondylitis. Bio-Thera believes these data provide confirmation that the proposed copy biological matches the reference medicine in terms of safety, efficacy and quality.

Bio-Thera is also developing a proposed copy biological of bevacizumab, which is currently being evaluated in a global phase III clinical trial. The company is also pursuing copy biologicals of tocilizumab, ustekinumab, secukinumab and golimumab.

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1.  Derbyshire M. Regulation of copy biologicals in China. Generics and Biosimilars Initiative Journal (GaBI Journal). 2018;7(2):75-6. doi:10.5639/gabij.2018.0702.015

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Source: Bio-Thera, Hisun

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