Innovent and Eli Lilly receive approval for rituximab copy biological in China

Biosimilares/Novedades | Posted 06/11/2020 post-comment0 Post your comment

Innovent Biologics and Eli Lilly have received joint marketing approval from the National Medical Products Administration (NMPA) in China for their rituximab copy biological, Halpryza. 

02 AA010638

Rituximab is a chimeric monoclonal antibody against the protein CD20, which is primarily found on the surface of immune system B cells. Rituximab destroys B cells and is therefore used to treat diseases that are characterized by excessive number of B cells, overactive B cells or dysfunctional B cells. This includes many lymphomas, leukaemias, transplant rejection, and autoimmune disorders such as rheumatoid arthritis. The originator product by Genentech is sold under the brand-name Rituxan.

On 9 October 2020, Innovent and Eli Lilly announced receiving joint NMPA marketing approval for their rituximab copy biological, Halpryza. Halpryza is an injectable drug and has been approved for the treatment of diffuse large B-cell lymphoma, follicular lymphoma, and chronic lymphocytic leukaemia. The approval is based on a number of clinical trials confirming the efficacy and safety of Halpryza.

Innovent and Eli Lilly began working together in 2015, initially for the development of TYVYT (sintilimab), an antibody treatment for Hodgkin lymphoma.

Halpryza is the fourth of Innovent’s monoclonal antibodies to be approved by the NMPA. The company has recently received approval for their adalimumab copy biological, Sulinno [1]. It has also received approvals for TYVYT (sintilimab) and Byvasda (bevacizumab).

Commenting on the news, VP and Head of Oncology Strategy and Medical Sciences at Innovent Dr Hui Zhou said: ‘Halpryza® (rituximab injection) is another example of our success with the National Major New Drug Innovation and Development Projects and the fourth monoclonal antibody drug approved by the NMPA […]’.

Senior VP of Lilly China Dr Li Wang added: ‘We’re excited that Lilly and Innovent strategic collaboration has reached another success. Lymphoma is one of the malignant tumours with rapid growing incidence. However, the survival rate is also relatively higher than other tumour types when having appropriate treatment. The approval of Halpryza® (rituximab injection) will bring a new option to Chinese lymphoma patients, help them to improve quality of life and prolong their survivals’.

South Korean firm Celltrion has recently launched its own rituximab biosimilar, Truxima, in Brazil [2], while Cadila has also launched a rituximab similar biologic, Ritucad, in India [3].

Related articles
China approves bevacizumab copy biological Byvasda

Positive phase Ib results for TYVYT + bevacizumab copy biological IBI305

WHO prequalifies first rituximab biosimilar

References
1. GaBI Online - Generics and Biosimilars Initiative. China approves adalimumab copy biological Sulinno [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Nov 6]. Available from: www.gabionline.net/Biosimilars/News/China-approves-adalimumab-copy-biological-Sulinno 
2. GaBI Online - Generics and Biosimilars Initiative. Celltrion launches Truxima in Brazil [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Nov 6]. Available from: www.gabionline.net/Biosimilars/News/Celltrion-launches-Truxima-in-Brazil 
3. GaBI Online - Generics and Biosimilars Initiative. Cadila Pharmaceuticals launches two similar biologics in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Nov 6]. Available from: www.gabionline.net/Biosimilars/News/Cadila-Pharmaceuticals-launches-two-similar-biologics-in-India 

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Source: Innovent

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