Biosimilarity. Do not confuse biosimilar and biocopy. Example of tenecteplase

Area of Science:

• Pharmacology
• Biotechnology
• Drug Development

Background:

• Non-innovator biological products (NIBPs), or 'biocopies,' are marketed at lower prices but may lack rigorous quality standards.
• These products can exhibit substantial differences in physicochemical and pharmacological properties compared to their reference biologics.
• Tenecteplase (TNK-tpA) is a thrombolytic agent for acute myocardial infarction; a biocopy, Elaxim®, is available in India.

Purpose of the Study:

• To evaluate whether Elaxim®, a tenecteplase biocopy, meets the criteria for a biosimilar to the originator product.
• To highlight the critical need for comprehensive quality and clinical data before marketing biological products as equivalent.

Main Methods:

• Literature review of available data on Elaxim® and originator tenecteplase.
• Comparative analysis of physicochemical and pharmacological properties.
• Assessment of available clinical data and trial design.

Main Results:

• Elaxim® shows substantially lower clot lysis activity than originator tenecteplase.
• The biocopy contains high concentrations of foreign proteins, posing potential immunological risks.
• Limited clinical data exists, with no randomized trials demonstrating equivalence to the originator.

Conclusions:

• Elaxim® cannot be considered a biosimilar to originator tenecteplase due to significant property differences.
• Confirmation of pharmaceutical quality, preclinical, and clinical data is mandatory for claiming clinical equivalence.
• This case underscores the importance of stringent evaluation for non-innovator biological products.