New insulin products will transition to being categorized as full-fledged biosimilars in 2020. The Biologic and Biosimilar Collective Intelligence Consortium has just published the results of an evaluation to determine whether its research network could detect safety signals in long-acting and intermediate-acting insulins used to treat type 1 and type 2 diabetes.
Published in the August 2019 Journal of Managed Care and Specialty Pharmacy, the BBCIC found that it could detect hypoglycemia and major adverse coronary events (MACEs) in a population of over 4,500 patients with type 1 diabetes and nearly 104,000 patients with type 2 diabetes who had taken insulin, based on available claims and health data. These proof-of-concept studies demonstrated the ability of the investigators to obtain data on insulin use (days supply and specific type of insulin, A1c levels, as well as adverse events).
The researchers found a similar incidence of hypoglycemia and MACE outcomes in patients with type 1 disease taking long-acting insulins compared with NPH insulins. In the type 2 study, they found that insulin was used for an average of 3.5 months, and patients had an average follow-up of 8.6 months, during the period of interest.
In the type 2 study, the BBCIC team found an unadjusted rate of severe hypoglycemic events of 96.9 per 10,000 patient-years at risk. The unadjusted incident MACE rate was 676.9 events per 10,000 patient-years. Over 38,000 of these patients had a baseline A1c level available among the records analyzed; fewer than 50% though had a follow-up A1c result entered into the records system.
Furthermore, in the type 2 study, the researchers were able to screen patients taking insulin in combination with (1) other insulin types as well as (2) second-generation sulfonylurea agents. Patients taking other medication combinations were not included in the data analysis.
Based on this work, BBCIC is confident that it will be able to conduct postmarketing surveillance on new innovator insulins as well as biosimilar insulins as they are introduced and tracked over time.
The BBCIC’s distributed research network can access 10 years of claims data covering approximately 100 million lives, including approximately 20 million active members in 2017 from 2 major US health plans and 3 regional integrated delivery networks.