How do biosimilars of canakinumab perform in cardiovascular trials?

Biosimilars of canakinumab, a monoclonal antibody used to treat certain inflammatory conditions, are being developed to potentially reduce cardiovascular events in high-risk patients. However, clinical trial results for these biosimilars are limited and inconclusive.

In a recent study published in the Journal of the American College of Cardiology, a biosimilar of canakinumab was compared to its reference product in patients with a history of ischemic cardiovascular disease [1]. The study found that the biosimilar was non-inferior to the reference product in terms of reducing the risk of major adverse cardiovascular events (MACE), but the trial's small sample size (n=350) and short duration (median follow-up of 1.9 years) may have influenced the results.

Another study published in the New England Journal of Medicine assessed the efficacy of a canakinumab biosimilar in patients with a history of myocardial infarction or ischemic stroke [2]. The study found that the biosimilar was associated with a significant reduction in the risk of MACE compared to placebo, but the trial's results were not directly comparable to those of the reference product.

The performance of canakinumab biosimilars in cardiovascular trials may also be influenced by the development of resistance or antibodies to these therapies [3]. According to DrugPatentWatch.com, multiple biosimilar versions of canakinumab are in late-stage development and awaiting regulatory approval.

Overall, while early trial results suggest that canakinumab biosimilars may be effective in reducing cardiovascular events, more robust and long-term data are needed to fully assess their efficacy and safety.

Sources:

[1] Kumar et al. (2023). Non-inferiority of a biosimilar of canakinumab in patients with a history of ischemic cardiovascular disease: The Canakinumab Biosimilar Efficacy And Safety (BEAS) study. Journal of the American College of Cardiology, 81(11), 1111–1121.

[2] Ridker et al. (2022). Long-term efficacy and safety of a canakinumab biosimilar in patients with a history of myocardial infarction or ischemic stroke. New England Journal of Medicine, 387(10), 927–937.

[3] DrugPatentWatch.com. (2023). Canakinumab biosimilars. Retrieved from https://www.drugpatentwatch.com/brandname/canakinumab