Creative Commons Open Access Journal No author-side fee 
  • Users Online: 174
  • Print this page
  • Email this page
Submit article
Year : 2019  |  Volume : 1  |  Issue : 1  |  Page : 8-14

Multicentric, randomized, double-blind, comparative study in STEMI patients to establish clinical biosimilarity of biosimilar tenecteplase with reference product

1 Medical Affairs Group, DALC, Reliance Life Sciences, Navi Mumbai, Maharashtra, India
2 Clinical Research Group, DALC, Reliance Life Sciences, Navi Mumbai, Maharashtra, India

Correspondence Address:
Dr. Prasad Apsangikar
Reliance Life Sciences, R-282, TTC Area of MIDC, Thane Belapur Road, Rabale, Navi Mumbai - 400 701, Maharashtra
Login to access the Email id

Source of Support: None, Conflict of Interest: None

DOI: 10.4103/ACCJ.ACCJ_6_18

Rights and Permissions

Objectives: Tenecteplase (TNK) is an established third-generation class 1A thrombolytic. The objective of the present study was to establish clinical biosimilarity of TNK biosimilar in a comparative phase III study with the reference product in the patients of ST elevation myocardial infarction (STEMI). Materials and Methods: In the double-blind, randomized, comparative clinical study 105 individuals were enrolled (70 in biosimilar TNK arm and 35 in the reference arm). Primary endpoint was thrombolysis in myocardial infarction (TIMI) 3-flow rate of the infarct-related artery at 90 min and all-cause mortality rate at 30 days' post dosing. Secondary endpoints considered were 50% resolution of elevated ST segment at 90 min, re-infarction till day 30, change in the left ventricular ejection fraction at day 30, events of ventricular tachyarrhythmias till day 30, and comparative pharmacokinetics. Immunogenicity was assessed along with the evaluation of safety at day 30. Results: TIMI grade 3-flow rate was achieved in 29 (43.28%) individuals in biosimilar arm and 14 (41.18%) individuals in the reference arm. The difference between the groups was statistically not significant (P = 0.8396). Four (5.71%) all-cause mortality were reported in biosimilar TNK arm compared to 2 (5.71%) in reference arm (all-cause mortality rate at 30 days' post dosing) and the difference between the two arms was statistically not significant (P = −1.00). Conclusion: Biosimilar TNK demonstrated biosimilar equivalence with the reference product in terms of the efficacy and safety analysis in this Phase III study and may be considered as a suitable alternative to reference TNK in patients with STEMI.

Print this article     Email this article
 Next article
 Previous article
 Table of Contents

 Similar in PUBMED
   Search Pubmed for
   Search in Google Scholar for
 Related articles
 Citation Manager
 Access Statistics
 Reader Comments
 Email Alert *
 Add to My List *
 * Requires registration (Free)

 Article Access Statistics
    PDF Downloaded446    
    Comments [Add]    

Recommend this journal