Adalimumab copy biological accepted for review in China Posted 15/11/2019

China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), has accepted an application for the approval of adalimumab copy biological UBP1211.

China-based Shanghai Junshi Biosciences announced on 8 November 2019 that its proposed adalimumab copy biological, UBP1211, had been accepted for review by the NMPA. The product is a copy biological of AbbVie’s Humira (adalimumab), which is indicated for the treatment of rheumatoid, juvenile idiopathic and psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis and ulcerative colitis.

The NMPA also accepted applications for approval of adalimumab copy biologicals from Bio‑Thera Solutions, Hisun Pharma and Innovent Biologics in August, September and November 2018, respectively [2, 3].

If approved, this will be Shanghai Junshi Biosciences first copy biological to be approved in China and the company says that it plans to launch its adalimumab copy biological in the country in 2020.

According to its website, Shanghai Junshi Biosciences is also working on secukinumab (JS005) and belimumab copy biologicals, which are currently in the phase I/II development stage.

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. The EMA (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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References
1. GaBI Online - Generics and Biosimilars Initiative. Copy biologicals approved in China [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Nov 15]. Available from: www.gabionline.net/Biosimilars/General/Copy-biologicals-approved-in-China
2. GaBI Online - Generics and Biosimilars Initiative. Adalimumab copy biologicals accepted for review in China [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Nov 15]. Available from: www.gabionline.net/Biosimilars/News/Adalimumab-copy-biologicals-accepted-for-review-in-China

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Source: Shanghai Junshi Biosciences, Yahoo

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