China approves rituximab copy biological

Biosimilares/Novedades | Posted 15/03/2019 post-comment0 Post your comment

China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), announced on 22 February 2019 that it had approved Hanlikon, a rituximab copy biological.

Rituximab V13D29

Hanlikon (HLX01) was developed by Shanghai Fuhong Hanlin Bio-Pharmaceutical (Hanlin), which is part of Shanghai Henlius Biotech (Henlius) and which in turn is a subsidiary of the Fosun Pharma Group.

Hanlikon has been approved for the treatment of non-Hodgkin’s lymphoma, including three subtypes: (1) treatment of relapsed or resistant follicular central lymphoma; (2) previously untreated CD20-positive stage III-IV follicular non-Hodgkin's lymphoma; (3) CD20bj diffuse large B-cell non-Hodgkin's lymphoma.

The NMPA says this is the country’s first ‘copy biological’ and that it follows the release of its Technical Guidelines for Development and Evaluation of Copy Biologicals (Trial), which was formulated and released in February 2015.

According to the NMPA, the rituximab product filed by Hanlin is ‘the first product in China to be researched and produced according to the copy biological drug route with rituximab as a reference drug’. The application included comprehensive data on quality similarity studies, non-clinical similarity studies and clinical comparison studies to obtain data on the safety and efficacy of the product.

The NMPA also says that China is currently the country with the most copy biologicals in research. The agency says that ‘nearly 200 copy biological drug clinical trial applications have been approved’. In addition, some products have already completed phase III trials and have submitted applications for approval.

Henlius also submitted an application for approval to China’s NMPA for its monoclonal antibody copy biological HLX22 in November 2018 [1].

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1. GaBI Online - Generics and Biosimilars Initiative. Monoclonal antibody copy biologicals accepted for review in China []. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Mar 15]. Available from:

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Source: NMPA

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