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Rituximab copy biological accepted for review in China Posted 09/08/2019

China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), has accepted an application for approval of rituximab copy biological IBI301.

China-based Innovent Biologics (Innovent) and US-based Eli Lilly announced on 27 June 2019 that its proposed rituximab copy biological IBI301 had been accepted for review by the NMPA. Eli Lilly and Innovent’s product is a copy biological of Roche’s MabThera/Rituxan (rituximab), which is used to treat many lymphomas, leukaemias, transplant rejection and autoimmune disorders.

The application for IBI301 is based on clinical data generated from two clinical studies, namely a phase III comparative study of efficacy and safety in patients with diffuse large B-cell lymphoma (DLBCL) and a pharmacokinetic (PK) study in patients with CD20-positive B-cell lymphoma. Both studies directly compare IBI301 to rituximab and have met their predefined primary endpoints.

This latest application marks the fourth that Innovent application accepted for review by the NMPA. An application for its adalimumab copy biological (IBI303) was accepted for review in November 2018 [1], its bevacizumab copy biological IBI305 was accepted in January 2019 [2]. The company also had an application for Tyvyt (sintilimab injection) approved by the NMPA and has successfully launched the product in China.

China has already approved one rituximab copy biological. The NMPA approved rituximab copy biological Hanlikon (HLX01), which was developed by Shanghai Fuhong Hanlin Bio-Pharmaceutical, in February 2019 [3].

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 article
Biosimilars of rituximab

References
1. GaBI Online - Generics and Biosimilars Initiative. Another adalimumab copy biological accepted for review in China [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Aug 9]. Available from: www.gabionline.net/Biosimilars/News/Another-adalimumab-copy-biological-accepted-for-review-in-China  
2. GaBI Online - Generics and Biosimilars Initiative. Monoclonal antibody copy biologicals accepted for review in China [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Aug 9]. Available from: www.gabionline.net/Biosimilars/News/Monoclonal-antibody-copy-biologicals-accepted-for-review-in-China 
3. GaBI Online - Generics and Biosimilars Initiative. China approves rituximab copy biological [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Aug 9]. Available from: www.gabionline.net/Biosimilars/News/China-approves-rituximab-copy-biological

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Source: Eli Lilly, Innovent

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