China publishes draft guideline for adalimumab copy biologicals

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On 1 April 2020, China’s Center for Drug Evaluation (CDE) published draft guidance on clinical trials for the approval of adalimumab copy biologicals.


The CDE, which is part of the National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA, 国家食品药品监督管理局) – the Chinese authority that oversees all drug manufacturing, trade and registration in the country – has released the draft guidance for a one-month consultation period.

Guiding Principles for Clinical Trials of Adalimumab Injection Copy Biologicals
Date: April 2020

The draft guidance outlines how ‘according to the principle of gradual progress’, companies should ‘conduct pharmaceutical, non-clinical and clinical comparison research in stages’.

The draft guidance covers how to perform pharmacokinetic comparisons in healthy subjects and assess clinical effectiveness in patients. The guidance refers back to the overarching guidance on the clinical study of copy biologicals in China [1], but also features issues specific to adalimumab and rheumatoid arthritis or ankylosing spondylitis patients taking adalimumab.

Adalimumab-specific issues discussed in the guidance include the criteria for selecting study subjects, including the disease activity levels for inclusion in the study, recommended dosing regimens, primary endpoint indicators and equivalence thresholds.

The draft guidance also covers the issue of extrapolation of indications, where it states that ‘the applicant must provide sufficient scientific evidence to support the application of indication extrapolation’.

The draft will be a welcome addition to the guidance on copy biologicals already published by the CDE [1]. Chinese companies known to be working on copy biologicals of adalimumab include Bio-Thera Solutions (Bio-Thera), Hisun Pharmaceuticals, Innovent Biologics and Shanghai Henlius Biotech, subsidiary of Fosun Pharma [2]. In fact, Bio-Thera announced in January 2020 that it had launched the first adalimumab copy biological in China [3].

The CDE is accepting feedback on the draft guidance until the end of April 2020.

Related article
Copy biologicals approved in China

1. GaBI Online - Generics and Biosimilars Initiative. Chinese guidelines for copy biologicals []. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Apr 24]. Available from:
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of adalimumab []. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Apr 24]. Available from:
3. GaBI Online - Generics and Biosimilars Initiative. Bio-Thera launches first adalimumab copy biological in China []. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Apr 24]. Available from:

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Source: CDE

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