AUTHOR=Kliche Werner , Krech Ingo , Michel Martin C., Sangole Nishant V., Sathaye Sadhana TITLE=Comparison of clot lysis activity and biochemical properties of originator tenecteplase (Metalyse®) with those of an alleged biosimilar JOURNAL=Frontiers in Pharmacology VOLUME=5 YEAR=2014 URL=https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2014.00007 DOI=10.3389/fphar.2014.00007 ISSN=1663-9812 ABSTRACT=
The bioengineered tissue plasminogen activator tenecteplase is an important treatment modality of acute myocardial infarction recommended by international guidelines. Following introduction of originator tenecteplase (brand names Metalyse® and TNKase®), a “biosimilar” tenecteplase became available for commercial use in India under the brand name Elaxim® in the absence of Indian biosimilar guidelines which came into force from September 15th, 2012. Based on a report of biochemical and fibrinolytical differences between Metalyse and Elaxim, we have systematically compared them in a range of routine quality testing assays. As compared to Metalyse, Elaxim exhibited less clot lysis activity and contained less of the two-chain form of tenecteplase. Even upon full