Comparative safety of insulin glargine-yfgn (a biosimilar insulin) in a real-world population with novel pharmacoepidemiology methods: prevalent new-user study and clone-censored weight approach

Univ Of North Carolina Chapel Hill, Chapel Hill NC

Investigators

Abstract

Project Summary/Abstract Significance: Access to insulin, a biologic drug, has become a burden for many patients due to high prices. Biosimilars offer a solution to overcome this burden. They are biologics that are highly similar to the originator- biologic but not an exact copy. They are designed to match the structure and clinical effects of the originator- biologic. In July 2021, insulin glargine-yfgn (Semglee) became the first interchangeable biosimilar insulin approved. However, the randomized trials used to support the approval of Semglee were small in sample size, short in duration, and lacked diversity. Thus, there is an urgent need for real-world evidence on the use and safety of Semglee compare the originator-biologic insulin glargine (Lantus). Specific Aims: The proposed project will provide valuable information to patients and stakeholders on the use and safety of Semglee in a real-world population and demonstrate novel pharmacoepidemiology methods to evaluate the safety and interchangeability of biosimilar insulins post-market approval. In Aim 1, we will quantify and characterize the switching patterns (e.g., Lantus-Semglee-Lantus) of patients who received a prescription for Semglee or Lantus and assess their characteristics to understand how patient characteristics influence biologic and biosimilar insulin use. In Aims 2 and 3, we will use novel pharmacoepidemiology methods to replicate and emulate the randomized trials used to support the approval of Semglee with real-world data and compare the rate of serious hypoglycemia between Semglee and Lantus. Approach: This study will compare the use and safety of Semglee to Lantus with real-world data from the Merative MarketScan database, a longitudinal administrative claims database of more than 250 million private insurance beneficiaries. In Aim 1, we will identify switching patterns (e.g., Lantus-Semglee-Lantus) among patients who received a prescription for Semglee or Lantus and assess their demographics and clinical characteristics at baseline, `time of first switch', and `time of first switchback'. In Aim 2, we will compare the rate of serious hypoglycemia between Semglee and Lantus over a 1-year follow-up period with the prevalent new- user study design. In Aim 3, we will emulate a randomized switching trial to compare the interchangeability (effect of switching) between Semglee and Lantus to continuous (non-switching) Lantus on the rate of serious hypoglycemia over a 9-month follow-up period with the clone-censor-weight approach. Fellowship Information: The principal investigator is a PhD student in Epidemiology at UNC. Dr. Her proposes a training plan that will equip him with the knowledge and skills to launch a career as an independently funded principal investigator in diabetes. His training plan consists of mentor research, coursework and seminar, and professional development that will take place in a thriving collaborative research environment, guided by an internationally recognized team of mentors.