Biocad's Rituximab Biosimilar Shows Safety, Efficacy in NHL, RA

Drug developer Biocad received approval for its rituximab biosimilar, BCD-020 (Acellbia) in Russia in 2014, and since that time, the drug has been launched in Russia and in multiple other markets around the world. While Biocad has not specified whether it plans to pursue regulatory approval for the biosimilar in the European Union, the company has announced ambitions to enter the EU market with some of its products, and researchers have published new data for the biosimilar in both oncology and rheumatology indications.

Writing in Hematological Oncology, a team of authors reported on an international, multicenter trial conducted among 174 patients with indolent lymphomas who had no previous biologic treatment for their disease.¹ In total, 89 patients received the biosimilar 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. Antidrug antibodies were detected in 2 patients, both in the reference arm, write the authors.

Researchers have also recently published data for the biosimilar used in a low dose in the treatment of rheumatoid arthritis (RA) in routine clinical practice.²

In the study, 20 patients with RA who were taking concomitant methotrexate were given a low-dose (600 mg) of the biosimilar on day 1 and day 15 as a first-line biologic. At week 24, 75%, 45%, and 15% of patients met American College of Rheumatology criteria for 20%, 50%, and 70% improvement, respectively.

In total, 15% of patients experienced mild infusion-related reactions. No patients had serious AEs.

Finally, another research team reported on the impact of the biosimilar versus the reference product in terms of biomarkers in patients in RA.³

In the study, 54 patients with RA were included. A total of 34 patients were treated with 2 infusions of the reference rituximab at a dose of either 500 mg or 1000 mg with concomitant glucocorticoids and disease-modifying antirheumatic drugs (DMARDs). Twenty patients were given 2 infusions of the biosimilar at a dose of 600 mg together with DMARDs and glucocorticoids.

In both treatment groups, there were decreases in erythrocyte sedimentation rate, levels of C-reactive protein, rheumatoid factors, and mutated citrullinated vimentin at weeks 12 and 24. Depletion of CD19-positive B cells was achieved at week 12 in all patients, and B cells increased at week 24.

According to the authors, the biosimilar and its reference have a similar effect on inflammatory and immunological biomarkers in RA.

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 [published online November 14, 2019]. Hematol Oncol. doi: 10.1002/hon.2693

2. Kusevich D, Avdeeva A, Rybakova V. Efficacy and safety of BCD-020 as a first-line biologic therapy in patients with active rheumatoid arthritis in clinical practice [published online April 4, 2019]. Int J Rheum Dis. doi: 10.1111/1756-185X.13533.

3. Avdeeva A, Cherkasova M, Artyuhov A, et al. Comparison of the effect of rituximab (Roche) and rituximab biosimilar—BCD-020 (Biocad) on inflammatory and immunological biomarkers in patients with rheumatoid arthritis [published online June 27, 2019]. Ann Rheum Dis. doi: 10.1136/annrheumdis-2019-eular.2748.