Biocad announces positive rituximab results and plans to enter EU market

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Biocad announces positive rituximab results and plans to enter EU market

Biosimilares/Investigación | Posted 17/01/2020 0 Post your comment

Russian biotechnology company Biocad has announced plans to enter the European market and has published positive results for its rituximab non-originator biological Acellbia (BCD-020).

Biocad made the announcement about entering the European Union (EU) market during the 30th anniversary CPhI Worldwide exhibition. This the company intends to do with two of its innovator monoclonal antibodies – an interleukin-17 inhibitor (inn-netakimab) and a PD-1 inhibitor (inn-progolimab).

The company also published results from an international, multicentre trial in 174 patients with indolent non-Hodgkin Lymphoma’s who had no previous biological treatment for their disease [1]. In total, 89 patients received Biocad’s rituximab non-originator biological (BCD-020) at a dose of 375 mg/m² for 4 weeks and 85 patients received the same dose of the reference drug.

The primary outcome was overall response rate (ORR) at day 50, and the prespecified equivalence margin was -20% to 20% for the 95% confidence interval (CI) for the difference in ORR. The ORR at day 50 was 44.71% in the biosimilar arm and 41.89% in the reference arm. The 95% CI for the difference in ORR was -12.62% to 18.24%, which fell within the prespecified equivalence margin. Adverse events (AEs) were reported in 68.54% of the biosimilar group and 69.41% of the reference group, respectively, and no unexpected AEs were reported. Anti-drug antibodies were detected in two patients, both in the reference arm.

The authors concluded that the study ‘showed equivalent efficacy of BCD‐020 and reference rituximab when used in patients with CD20‐positive indolent lymphomas’. They also said that the study ‘confirmed pharmacokinetic equivalence of BCD‐020 and reference rituximab. Safety profile, pharmacodynamics and immunogenicity of BCD‐020 were also comparable to those of reference rituximab’.

Biocad also published positive results for BCD-020 in the treatment of rheumatoid arthritis (RA) in July 2019 [2].

The company received approval for Acellbia (BCD-020) in Russia in April 2014 and in India in July 2017 [3].

References
1. Poddubnaya IV, Alekseev SM, Kaplanov KD, et al. Proposed rituximab biosimilar BCD‐020 versus reference rituximab for treatment of patients with indolent non‐Hodgkin lymphomas: an international multicenter randomized trial. Hematol Oncol. doi:10.1002/hon.2693
2. GaBI Online - Generics and Biosimilars Initiative. Positive results for rituximab non-originator and copy biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jan 17]. Available from: www.gabionline.net/Biosimilars/Research/Positive-results-for-rituximab-non-originator-and-copy-biologicals
3. GaBI Online - Generics and Biosimilars Initiative. Biocad’s rituximab ‘similar biologic’ recommended for approval in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jan 17]. Available from: www.gabionline.net/Biosimilars/News/Biocad-s-rituximab-similar-biologic-recommended-for-approval-in-India

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Source: Biocad