FDA approves first interchangeable biosimilar insulin

Abstract

FDA approves first interchangeable biosimilar insulinI n July 2021, FDA approved the first interchangeable biosimilar insulin product (Semglee-Viatris/Biocon Biologics, insulin glargineyfgn), which can be substituted for its reference product (Lantus-Sanofi Aventis, insulin glargine) at the pharmacy level, depending on state pharmacy laws. Although FDA first approved Semglee in June 2020 to improve glycemic control in pediatric patients with type 1 diabetes and adults with type 1 or type 2 diabetes, this approval marks the first interchangeable biosimilar designation for insulin from the agency."The approval of an interchangeable insulin glargine may offer cost savings to select patients, as biosimilars have, on average, launched with lower initial prices compared with their branded counterparts," said Daphne Smith Marsh, PharmD, BC-ADM, CDCES, a clinical pharmacist in ambulatory pharmacy services at Mile Square Health Center in Chicago. However, she added there are several other considerations that health care practitioners must keep in mind."Pharmacists should understand that Semglee can be substituted for Lantus without intervention of the prescriber, but currently cannot be interchanged with Basaglar-Lilly, another insulin glargine product on the market," she said. "If patients previously receiving Lantus are given Semglee at the pharmacy, patient education is essential to avoid duplication of therapy, as some patients may not understand that they are the same type of medications and may continue to use both products once they get home." Understanding biosimilars and interchangeabilityMaria G. Tanzi, PharmD, contributing writer. Tanzi is an employee of Incyte Corporation. The opinions expressed in this article are those of the author and do not represent the views of Incyte.

Meal and Physical Activity Detection from Free-Living Data for Discovering Disturbance Patterns of Glucose Levels in People with Diabetes

“…In this work, the estimation of the PIC and glucose appearance rate were obtained from a physiological model known as Hovorka's model [43]. Equation (9) presents this nonlinear physiological (compartment) model:…”

“…Model ( 9) comprises four sub-models, describing the action of insulin on glucose dynamics, the insulin absorption dynamics, plasma-interstitial-tissue glucose concentration dynamics, and the blood glucose dynamics.The state variables of (9), the nominal values of the parameters, and their units are listed in Table 4 [43].…”

“…In recent years, the number of people with diabetes has grown rapidly around the world, reaching pandemic levels [2,3]. Advances in continuous glucose monitoring (CGM) systems, insulin pump and insulin pen technologies, and in novel insulin formulations has enabled many powerful treatment options [4][5][6][7][8][9]. The current treatment options available to people with T1D range from manual insulin injections to AID.…”

Estimated Changes in Insulin Prices and Discounts After Entry of New Insulin Products, 2012-2019

“…In 2020, the US Food and Drug Administration redesignated insulin from a drug to a biologic, allowing for the introduction of interchangeable biosimilar products . As of August 2022, only 1 interchangeable biosimilar insulin has been approved (insulin glargine-yfgn [Semglee]) …”

“…14 As of August 2022, only 1 interchangeable biosimilar insulin has been approved (insulin glargine-yfgn [Semglee]). 15 …”