US-based pharma giant Eli Lilly, and its partner China-based Innovent Biologics (Innovent), announced on 7 May 2019 positive data from two clinical studies of their rituximab copy biological (IBI301) compared to Rituxan (rituximab).
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.
The phase I pharmacokinetic (PK) study (CIBI301A201) is a randomized, double-blinded, parallel, positive-controlled, single-dose clinical trial. It enrolled 181 patients with CD20-positive B-cell lymphoma and compared the PK profile, safety, tolerability and immunogenicity of IBI301 with Rituxan. It was carried out in China and was completed in April 2018.
The phase III study (CIBI301A301) is a multicentre, randomized, double-blinded, parallel, positive-controlled phase III clinical trial. It enrolled 420 patients with diffuse large B-cell lymphoma (DLBCL) and evaluated the efficacy and safety of IBI301 and Rituxan in the first-line treatment of patients with newly diagnosed DLBCL. The objective of the study was to compare the clinical activity and safety between IBI301 and rituximab when each is used in combination with standard chemotherapy [cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP)] in patients with diffuse DLBCL. It was also carried out in China and was completed in December 2018.
The results of both studies ‘met pre-defined primary endpoints’, according to Eli Lilly and Innovent. For the phase I PK study the primary objective was to compare the PK profile of the two agents. For the phase III study the primary endpoint was objective response rate (ORR). The companies say that ‘the details of these studies will be disclosed in future publications in scientific journals and conferences’.
DLBCL is the most common type of lymphoma in China and rituximab is the standard treatment for DLBCL patients.
Heads of Innovent and Eli Lilly China said that the results of the clinical studies of IBI301 were ‘encouraging’ and had ‘significant clinical value’. They added that they hoped ‘that IBI301 can be approved soon’ and ‘that the launch of IBI301 in the China market will improve its affordability, so more patients with lymphoma can benefit from the drug’.
Innovent already had an adalimumab copy biological accepted for review by the China National Drug Administration (CNDA), formerly the China Food and Drug Administration (CFDA), in November 2018 [1].
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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Reference
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 May 31]. Available from: www.gabionline.net/Biosimilars/News/Another-adalimumab-copy-biological-accepted-for-review-in-China
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Source: clinicaltrials.gov, Innovent Biologics
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