Secukinumab Biosimilar Demonstrates Pharmacokinetic Equivalence

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CMAB015, a secukinumab biosimilar, has demonstrated equivalent pharmacokinetics (PK) and comparable safety and immunogenicity to the reference drug in a double-blind study (NCT05734482) in healthy male participants conducted in China.¹

“IL-17A is considered a pivotal proinflammatory cytokine in the pathogenesis of various diseases, including psoriasis, psoriatic arthritis, rheumatoid arthritis, and ankylosing spondylitis. Secukinumab, a selective anti-IL17A monoclonal antibody, has demonstrated efficacy and safety in treating these conditions. Biosimilars of secukinumab, such as CMAB015, offer cost-effective alternatives that are equivalent in efficacy and safety, providing patients with psoriasis or ankylosing spondylitis with more treatment options,” lead investigator Feng Yao, Department of Clinical Pharmacology, The Second Affiliated Hospital of Anhui Medical University, Hefei, People’s Republic of China, and colleagues.¹

Yao and colleagues conducted a double-blind, parallel-group study that evaluated 130 participants randomized to receive either a single dose of 150 mg CMAB015 or reference subcutaneously. They primarily assessed PK parameters including maximum concentration (Cmax) and area under the curve from zero to infinity (AUC0-inf), and secondarily assessed safety and immunogenicity.

The investigators found that the geometric mean ratio (GMR) for CMAB015/secukinumab was 104.05% for Cmax and 95.70% for AUC0-inf, with 90% confidence intervals (Cis) within the bioequivalence limits of 80.00–125.00%.¹

CMAB015 also had a comparable safety profile to reference secukinumab and participants experienced no serious adverse events (AEs). The CMAB015 group had a slightly higher incidence rate of mild-to-moderate treatment-emergent AEs (n = 53; 81.5%; 136 events) than the reference group (n = 48; 73.8%; 110 events) but these did not lead to any study withdrawals. There were similar, low rates of anti-drug antibody (ADA) positivity between biosimilar (n = 2; 3.1%) and reference groups (n = 1; 1.5%).¹

“This study illustrated the equivalent PK profiles of the secukinumab biosimilar (CMAB015) and the reference product (secukinumab) in healthy Chinese male subjects after a single subcutaneous injection. Moreover, the safety profiles and immunogenicity of CMAB015 were similar to those of secukinumab. These findings support the further development of CMAB015 as a biosimilar to secukinumab and its potential to provide an effective and affordable treatment option for patients with inflammatory diseases,” Yao and colleagues concluded.¹

Recent, real-world experience research with secukinumab has demonstrated efficacy for up to 5 years in a cohort of patients with psoriasis and psoriatic arthritis (PsA), with high drug survival (DS), in a retrospective analysis.²

Psoriasis Area Severity Index (PASI)100 was achieved by 41.7% of patients at week 16 and 70.6% of patients at week 260. Similarly, 46.5% of patients were able to obtain PASI90 at week 16 and 88.2% at week 260. The main cause of secukinumab discontinuation was drug inefficacy (50.4%). The adverse events reported, such as rhinitis, diarrhea, candidiasis, otitis, and transaminitis, did not often lead to discontinuation. Other reasons for discontinuation included primary failure (17.7%).²

REFERENCES

1. Yao F, Wang C, Ding J, et al. A Randomized, Double-Blind, Parallel-Group Phase I Study Comparing the Pharmacokinetics, Safety, and Immunogenicity of CMAB015, a Candidate Secukinumab Biosimilar, with Its Reference Product Cosentyx® in Healthy Chinese Male Subjects. Drug Des Devel Ther. 2024 (18):3891-3901. doi:10.2147/DDDT.S470619
2. Mastorino L, Dapavo P, Cariti C, et al. Drug Survival, Safety, and Effectiveness of Secukinumab for up to 5 Years in Patients with Psoriasis and Psoriatic Arthritis: A Long-Term Real-Life Experience. J Pers Med. 2024;14(7):718. Published 2024 Jul 3. doi:10.3390/jpm14070718