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Positive results for rituximab non-originator and copy biologicals Posted 26/07/2019

Positive results for the rituximab non-originator biological BCD-020 (AcellBia) and for the rituximab copy biological HLX01 (Hanlikon) have been presented at the European Congress of Rheumatology 2019 (EULAR 2019) [1, 2].

AcellBia (BCD-020) is made by Russian biotechnology company Biocad. It was approved by the Russian Ministry of Health in April 2014 [3].

The study with Biocad’s BCD 020 compared the effect of Roche’s rheumatoid arthritis blockbuster MabThera/Rituxan (rituximab) to BCD-020 on inflammatory and immunological biomarkers in patients with rheumatoid arthritis [RA] [1]. It included 54 RA patients and evaluated the changes in acute phase reactants, autoantibodies, immunoglobulins, cytokine profile and CD19+B lymphocytes in patients with RA during therapy with originator and non-originator (BCD 020) rituximab.

The results showed that both originator rituximab and BCD-020 induced decreases in erythrocyte sedimentation rate (ESR), levels of C-reactive protein (CRP), immunoglobulin M rheumatoid factor (IgMRF), immunoglobulin arthritis rheumatoid factor (IgARF), anti-mutated citrullinated vimentin (anti-MCV) at Week 12 and Week 24, p < 0.05. Levels of anti-cyclic citrullinated peptide (anti-CCP2) were not reduced. Depletion of CD19+B cells was achieved at Week 12 in all patients (absolute number 0), with an increase in the level of B cells at Week 24 and the immunoglobulin level decreased at Week 24.

Based on these results the authors concluded that ‘BCD 020 has a similar effect on inflammatory and immunological biomarkers to the originator rituximab’. They added that ‘BCD 020 therapy induced a rapid and significant improvement in ESR, levels of CRP, IgM/IgARF, anti-MCV, pro-inflammatory, anti-inflammatory cytokines, growth factors, chemokines levels and CD19+B cells depletion in RA patients’.

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. It was approved by China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA) in February 2019 [4].

The study with Hanlin’s HLX01 compared the pharmacokinetics (PK), pharmacodynamics (PD), safety and exploratory efficacy between HLX01 and European-sourced rituximab (EU-RTX) in Chinese patients with moderate to severe RA [2]. A total of 196 RA patients were randomized using a 1:1 ratio in the multicentre, randomized, double-blind, parallel, active-controlled, clinical trial. Of those randomized subjects, 179 were included in the PK pre-protocol set (PPS): 88 in the HLX01 group and 91 in the EU-RTX group.

The results showed that the 90% confidence intervals (CI) for the ratio of geometric means for the pairwise comparisons of the primary PK endpoint AUC (0-inf), as well as AUC (0-14d), AUC (0-t,1), AUC (15d-t), Cmax 1, Cmax 2, and Cmin were within the pre-specified limits of 80%−125%. ACR20 and DAS28-CRP results at Week 24 for the HLX01 group and EU-RTX group were also similar. In addition, there was also no statistical difference in safety and immunogenicity between the two treatment groups.

Based on these results the authors concluded that this study successfully demonstrated the ‘similarity in PK, safety and initial efficacy between the first China-manufactured copy biological of rituximab, HLX01, and Europe-sourced rituximab in patients with moderately to severely active rheumatoid arthritis’. They added that ‘these results support the phase III confirmatory clinical trial for the development of HLX01 for the treatment of rheumatoid arthritis’.

These results were presented at the European Congress of Rheumatology 2019, which took place on 12‒15 June 2019 in Madrid, Spain.

Conflict of interest
The authors of the abstracts [1, 2] reported conflicts of interest, including being employees of pharmaceutical companies. For full details of the authors’ conflict of interest, see the abstracts [1, 2].

Editor’s comment
It should be noted that data of the studies presented in this article were published as abstracts and presented at a conference. These data and conclusions should be considered as preliminary until published in a peer-reviewed journal.

It should be noted that non-originator biologicals approved in Russia and 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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References
1. Avdeeva A, Cherkasova M, Artyuhov A, et al. AB0366 (2019): Comparison of the effect of rituximab (Roche) and rituximab biosimilar – BCD-020 (Biocad) on inflammatory and immunological biomarkers in patients with rheumatoid arthritis. European Congress of Rheumatology 2019; 2019 Jun 12−15; Madrid, Spain.
2. Zeng X, Wang Y, Jiang Z, et al. SAT0139 (2019): A multicentre, randomised, double-blind, parallel active-controlled clinical trial comparing pharmacokinetics, pharmacodynamics, safety and exploratory efficacy between HLX01 and Europe-sourced rituximab as a new indication in Chinese moderate to severe patients with rheumatoid arthritis. European Congress of Rheumatology 2019; 2019 Jun 12−15; Madrid, Spain.
3. GaBI Online - Generics and Biosimilars Initiative. Rituximab non-originator biological approved in Russia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jul 26]. Available from: www.gabionline.net/Biosimilars/News/Rituximab-non-originator-biological-approved-in-Russia 
4. GaBI Online - Generics and Biosimilars Initiative. China approves rituximab copy biological [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jul 26]. Available from: www.gabionline.net/Biosimilars/News/China-approves-rituximab-copy-biological 

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