China-based Innovent Biologics (Innovent) has received marketing authorization from the National Medical Products Administration (NMPA) for their adalimumab copy biological Sulinno.
Innovent is a biopharmaceutical company based in China, specializing in biological drugs such as monoclonal antibodies for the treatment of cancer, metabolic and autoimmune diseases.
On 3 September 2020, Innovent announced NMPA approval for their adalimumab copy biological Sulinno, the third of Innovent’s monoclonal antibodies to be approved by the NMPA.
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, for which there are 20 million patients in China.
Sulinno has been approved for the treatment of rheumatoid arthritis, ankylosing spondylitis and psoriasis, but not other conditions such as inflammatory bowel disease.
The drug has demonstrated therapeutic equivalence and shown highly similar safety and immunogenicity outcomes to reference adalimumab (Humira) in patients with ankylosing spondylitis. The results were published in the Lancet Rheumatology in 2019 [1].
Commenting on the approval, Founder, Chairman and CEO of Innovent Dr Michael Yu said: ‘As an example of our success with the National Major New Drug Innovation and Development Projects, SULINNO® is the third monoclonal antibody drug approved by the NMPA following TYVYT® (sintilimab injection) and BYVASDA® (bevacizumab injection), and the first drug marketed among Innovent’s non-oncology pipeline. The launch of SULINNO® once again fulfilled our mission to develop and commercialize high quality biopharmaceutical products that are affordable to ordinary people. We hope that this product will benefit more and more patients and families in need and improve their quality of life’.
The company had received NMPA approval for their sintilimab copy biological, TYVYT, for the treatment of patients with Hodgkin’s lymphoma in December 2018, and bevacizumab copy biological, Byvasda, for the treatment of patients with advanced non-small cell lung cancer and metastatic colorectal cancer in June 2020 [2].
Innovent is also working on an ipilimumab copy biological, IBI310, which activates the immune system by targeting cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), a protein receptor that down regulates the immune system, it recently reported positive phase I trial results [3].
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.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Adalimumab copy biological shown to be safe and effective [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Oct 9]. Available from: www.gabionline.net/Biosimilars/Research/Adalimumab-copy-biological-shown-to-be-safe-and-effective
2. GaBI Online - Generics and Biosimilars Initiative. China approves bevacizumab copy biological Byvasda [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Oct 9]. Available from: www.gabionline.net/Biosimilars/News/China-approves-bevacizumab-copy-biological-Byvasda
3. GaBI Online - Generics and Biosimilars Initiative. Positive phase I results for Innovent’s ipilimumab copy biological [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Oct 9]. Available from:
www.gabionline.net/Biosimilars/Research/Positive-phase-I-results-for-Innovent-s-ipilimumab-copy-biological
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