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.

Related articles
Rituximab copy biological accepted for review in China

Biosimilars of adalimumab

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

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing. 

Copyright – Unless otherwise stated all contents of this website are © 2019 Pro Pharma Communications International. All Rights Reserved.