Celltrion presented new data at the American College of Rheumatology (ACR) Convergence 2024, supporting the biosimilarity of CT-P41, a denosumab biosimilar candidate, and CT-P47, a tocilizumab biosimilar candidate. The studies provide evidence for comparable efficacy and safety profiles, potentially expanding treatment options for osteoporosis and rheumatoid arthritis (RA). Additionally, real-world data suggests that switching between rituximab biosimilars does not increase adverse events, and financial incentives may boost biosimilar uptake in oncology.
Denosumab Biosimilar CT-P41 Shows Sustained Efficacy and Safety
Data from a Phase 3 randomized controlled trial (RCT) of CT-P41 in postmenopausal women with osteoporosis (PMO) demonstrated comparable efficacy and safety to reference denosumab over 78 weeks. The study, which included switching data from reference denosumab to CT-P41, showed sustained efficacy after the transition. CT-P41 was well-tolerated, with a safety profile similar to the reference product. No notable safety issues were identified following the switch, according to Celltrion.
In the trial, 422 participants were randomized at Week 52 to CT-P41 maintenance (n = 221), denosumab maintenance (n = 100), or switch to CT-P41 (n = 101). The mean percent change of bone mineral density (BMD) for the lumbar spine, total hip, and femoral neck increased comparably among groups from baseline to week 78. One patient (0.5%) in the CT-P41 maintenance group experienced a new vertebral fracture at Week 78. Nonvertebral fractures were reported in 2 (0.9%) patients in the CT-P41 maintenance group and 1 (1.0%) patient in the switch to CT-P41 group. No hip fractures were reported.
An analysis of immunogenicity data from the Phase III RCT revealed that anti-drug antibodies (ADA) did not impact pharmacokinetics, efficacy, or safety in any of the treatment groups. Hetal Patel, PharmD, MBA, Head of Medical Affairs at Celltrion USA, stated, "We are excited to announce the additional evidence from the RCT that further supports the biosimilarity between CT-P41 and reference denosumab in treating PMO."
Tocilizumab Biosimilar CT-P47 Demonstrates Comparable Outcomes in Rheumatoid Arthritis
Results from a Phase 3 RCT evaluating CT-P47 in patients with active moderate-to-severe RA showed comparable efficacy, safety, and immunogenicity profiles to reference tocilizumab over one year, even after switching. The study included 471 patients with moderate to severe RA who had an inadequate response to at least one disease-modifying antirheumatic drug (DMARD). Participants were randomized to receive 8 mg/kg of CT-P47 or reference tocilizumab intravenously every 4 weeks up to Week 20.
The investigators found that the mean change from baseline of DAS28 was not affected by the transition from reference tocilizumab to CT-P47 at Week 24. Comparable improvements in clinical activity were observed up to Week 52 as measured by American College of Rheumatology (ACR)20/50/70 responses and remissions by clinical disease activity index (CDAI), simplified DA (SDAI), and Boolean-definition (v2.0).
"Biosimilars offer cost savings and health gains for our patients and play an important role in treating rheumatic diseases," said Prof. Gerd-Rüdiger Burmester, MD, Professor of Medicine and Rheumatology at Charité - Universitätsmedizin Berlin. "The RCT data of CT-P47 presented at ACR further establish the comparable safety and efficacy of biosimilars to their reference products."
Real-World Evidence Supports Rituximab Biosimilar Switching
A recent study published in Cancers found that switching between rituximab biosimilars does not increase the risk of adverse events in patients with oncohematological diseases. The study included 505 patients who received 3681 infusions, 77% of which were biosimilars. Investigators reported a higher incidence of adverse reactions among patients who did not switch medication (20.7%) compared to those who switched (3.5%).
Financial Incentives May Drive Biosimilar Adoption in Oncology
Findings published in PLoS One suggest that financial incentives for hospitals could increase the utilization of biosimilars, particularly in oncology. The study, which analyzed data from over 500 hospitals in Japan, found that financial incentives were associated with a 0.092 per month increase in the proportion of biosimilar prescriptions (95% CI, 0.040-0.145) compared to hospitals without incentives.
