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China extends indications for adalimumab and bevacizumab copy biologicals

Biosimilars/News | Posted 05/02/2021 0 Post your comment

Chinese biopharmaceutical firm Innovent Biologics (Innovent) announced that China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), has approved new indications for its adalimumab and bevacizumab copy biologicals.

Innovent announced on 22 December 2020 that Sulinno (adalimumab), a recombinant human anti-tumour necrosis factor alpha (TNF-α) monoclonal antibody drug, had been approved by the NMPA for two new indications. These new indications include the treatment of paediatric plaque psoriasis and non-infectious intermediate uveitis, posterior uveitis and panuveitis in adults who do not respond adequately to corticosteroids, require restraint of corticosteroids, or are not suitable for corticosteroid therapies. These are the fifth and sixth approved indications for Sulinno in China.

Sulinno was initially approved by China’s NMPA on 2 September 2020 for treatment of rheumatoid arthritis, ankylosing spondylitis, psoriasis and polyarticular juvenile idiopathic arthritis [1].

Innovent announced on 28 December 2020 that Byvasda (bevacizumab), a recombinant humanized anti-vascular endothelial growth factor (VEGF) monoclonal antibody drug developed by partner Innovent, had been approved by the NMPA for the treatment of adult recurrent glioblastoma (the most common malignant primary brain tumour), which is the third approved indication of Byvasda in China.

Byvasda was initially approved by the NMPA on 17 June 2020 for the treatment of patients with advanced non-small cell lung cancer and metastatic colorectal cancer [2].

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References
1. GaBI Online - Generics and Biosimilars Initiative. China approves adalimumab copy biological Sulinno [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Feb 5]. Available from: www.gabionline.net/Biosimilars/News/China-approves-adalimumab-copy-biological-Sulinno
2. GaBI Online - Generics and Biosimilars Initiative. China approves bevacizumab copy biological Byvasda [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Feb 5]. Available from: www.gabionline.net/Biosimilars/News/China-approves-bevacizumab-copy-biological-Byvasda

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Source: Innovent