Biosimilar Tenecteplase Demonstrates Utility vs Reference Agent for Acute Ischemic Stroke


A single-center study from India sheds light on the safety and efficacy of biosimilar tenecteplase relative to the reference agent for patients with acute ischemic stroke.

Professor Rohit Bhatia | Credit: LinkedIn

Professor Rohit Bhatia
Credit: LinkedIn

For patients with acute ischemic stroke, there was no difference in outcomes with biosimilar tenecteplase relative to the reference agent, according to the results of a real-world study.1

A retrospective analysis of real-world data from a single tertiary care center in India, results of the study, which included data from 160 patients with acute ischemic stroke, suggests there were no observed difference in safety and efficacy of tenecteplase and bio similar tenecteplase.1

“In our study, patients treated with either [reference tenecteplase] or [biosimilar tenecteplase] showed no difference in the functional outcome at 3 months; the same is in line with the recently and previously published RCTs comparing the two agents like AcT trial from Canada and TASTE‑A trial which have also suggested equivalence among the 2 molecules,” investigators wrote.1

According to investigators, uptake of biosimilars in India, as with the US and other parts of the globe, has been slow despite prospect of lower costs. Among US practitioners, common reasons cited for a lack of uptake include lack of knowledge and difficulties imposed by current policy.2

Despite approval by regulatory agencies in the country for use in 2017, biosimilar tenecteplase has been burdened by concerns regarding the noninferiority of the agent relative to its reference product. Led by Rohit Bhatia, professor in the Department of Neurology at All India Institute of Medical Sciences, the current study was conducted with the intent of exploring the differences in safety and efficacy of the biosimilar and reference agent among people with acute ischemic stroke at a single center.1

The time period of interest for the study was January 2018-July 2021. For inclusion, all patients needed to be eligible for intravenous thrombolysis, undergo an urgent non-contrast CT to rule out intracranial hemorrhage, and undergo a CT angiography to rule out large vessel occlusion. Investigators pointed out the decision to use either of the agents was made by the treating physician.1

The primary efficacy outcomes of interest were mRS at 90 days and recanalization TICI grade 2b/3 at first angiography run and end of endovascular therapy. The safety outcome of interest was rate of any intracerebral hemorrhage.1

Overall, a total of 160 patients were identified for inclusion. Of these, 103 received reference tenecteplase and 57 receive biosimilar tenecteplase. When compared to one another, results indicated the proportion of those who were male and had a history of hypertension were more frequency in the biosimilar tenecteplase group, but other baseline characteristics were well balanced between the study arms. Overall, the reference tenecteplase group had a mean age of 54 (SD, 15) years, 60.20% were male, and the median NIHSS score was 9 (IQR, 5‑13). In the biosimilar tenecteplase group,the mean age was 57 (SD, 12) years, 75.44% were male, and the median NIHSS score was 8 (IQR, 4‑14). Investigators pointed out the most frequent stroke subtype among both groups was large artery atherosclerosis.1

Upon analysis, results suggest good functional outcomes were observed among 47.92% of the biosimilar tenecteplase group and 64.77% of the reference tenecteplase group (P=.069). Further analysis suggested there was no difference in rates of any intracerebral hemorrhage (P=.29) or mortality (P=.32) at 3 months between either arm of the study.1

“In our study, we found that biosimilar tenecteplase has a similar efficacy and safety profile when compared to reference tenecteplase as observed in a real‑world scenario. Further studies are needed and are ongoing to compare the two molecules” investigators added.1


  1. Mohan A, Komakula S, Murali S, et al. Biosimilar Tenecteplase Versus Alteplase in Acute Ischemic Stroke: A Real World Study. Ann Indian Acad Neurol. 2023;26(1):54-58. doi:10.4103/aian.aian_754_22
  2. Pine L. Bruce Feinberg, do: Differences among specialties in biosimilar uptake. HCP Live. Published March 20, 2023. Accessed April 17, 2023.

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