The China National Drug Administration (CNDA), formerly the China Food and Drug Administration (CFDA) has accepted another application for approval of an adalimumab copy biological, this time from Innovent Biologics (Innovent).
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.
Innovent announced on 13 November 2018 that its proposed adalimumab copy biological IBI303 had been accepted for review by the CNDA. Innovent’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.
Innovent’s application for IBI303 is based on analytical, clinical and pharmacokinetics data generated from three clinical studies. Phase III comparative efficacy and safety studies were conducted in patients with ankylosing spondylitis. Pharmacokinetic parameters and immunogenicity of IBI303 were also compared directly against adalimumab in studies.
Innovent says that although ‘Humira has been globally recognized for its high efficacy and acceptable safety profile … its adoption rate in China is relatively low’. This is most likely due to the ‘high price of the branded drug’. This means that ‘many patients in China have difficulty getting treatment for these chronic diseases which require long-term medication’. In contrast, Innovent says that its adalimumab copy biological (IBI303) ‘offers a high quality and affordable alternative to Chinese patients’.
This marks the third adalimumab copy biological to have been accepted by the CNDA in 2018. On 24 August and 15 September 2018, the CNDA accepted applications for approval of adalimumab copy biologicals from Hisun Pharma (Hisun) and Bio‑Thera Solutions (Bio‑Thera), respectively.
Innovent is also developing proposed copy biologicals of bevacizumab (IBI305) and rituximab (IBI301), both of which have entered phase III clinical trials. The company also raised a further HK$3.3 billion (US$421 million) in funding from its Hong Kong initial public offering (IPO). This can add to the US$25 million in Series B financing that the company raised back in 2012 for continued expansion of its pipeline and manufacturing capabilities [1].
Editor’s comment
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. 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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Reference
1. GaBI Online - Generics and Biosimilars Initiative. China-based Innovent gains funding for expansion [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 17]. Available from: www.gabionline.net/Biosimilars/News/China-based-Innovent-gains-funding-for-expansion
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Source: CNDA, Innovent Biologics
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