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ABSTRACT
Introduction: The global incidence of diabetes mellitus is increasing, with a concomitant rise in individual and overall treatment costs. The development of biosimilars contributes to the facilitation of greater access to treatment. SAR342434 is a biosimilar follow-on of insulin lispro, a key therapeutic for the treatment of diabetes mellitus, and it is currently under phase III clinical trials.
Areas covered: In this review we discuss the recent updates on clinical data obtained from phase III trials to compare the equivalence and similarity of SAR342434 to insulin lispro, including pharmacokinetics (PKs), pharmacodynamics, clinical efficacy, safety and immunogenicity.
Expert opinion: The rising treatment costs of diabetes mellitus poses a challenge to public health enterprises worldwide. The development of biosimilars is probably a good choice to solve this conundrum. Based on the available clinical trials, it is confirmed that SAR342434 is equivalent to the reference insulin lispro, with similar pharmacodynamics, PKs, anti-hyperglycemic efficacy and safety. These attributes show the good potential of SAR342434 for serving as an alternative to achieve the glycemic control in patients with diabetes mellitus.
Declaration of interest
The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.
Reviewer Disclosures
Peer reviewers on this manuscript have no relevant financial relationships or otherwise to disclose.