Semglee (insulin glargine-yfgn) / PiSA Farmaceutica, Biocon, Viatris - LARVOL DELTA

UPTAKE OF BIOSIMILARS TO INSULIN GLARGINE IN 2021-2025 IN THE UNITED STATES (ISPOR 2026) - "Insulin glargine-yfgn (Semglee®) is the first interchangeable biosimilar to Lantus® approved by the U.S. FDA in July 2021. A second biosimilar, insulin glargine-aglr Rezvoglar®), was approved in December 2021 and designated interchangeable status in November 2022... Mild uptake of insulin glargine biosimilars in the insured populations was observed within the first 4 years of marketing in the U.S. Further exploration of factors to access such as provider and patient education, policy implementation, and reimbursement reform is warranted to foster stronger biosimilar adoption."

Diabetes • Metabolic Disorders

COMPARISONS OF MEDICAL AND PRESCRIPTION DRUG EXPENDITURES BETWEEN AMERICANS WHO USED INSULIN GLARGINE LANTUS AND ITS INTERCHANGEABLE BIOSIMILAR SEMGLEE (ISPOR 2026) - "As a biosimilar, Semglee led to lower total and OOP prescription drug expenditures for both healthcare system and consumers compared to Lantus, without increasing total medical expenditures. The higher OOP medical expenditures for Semglee users might be due to private insurance plan cost-sharing benefit design. Findings of this study call for real-world evidence research to compare effectiveness and safety between Lantus and its biosimilars for further adoption of biosimilars."

Insulins for type 2 diabetes. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Comparison chart: Some available insulins for type 2 diabetes. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

CivicaScript announces availability of low-cost insulin and biosimilar for chronic inflammatory conditions in the US (PRNewswire) - "CivicaScript sells ustekinumab-aauz in pre-filled syringes for subcutaneous injection in two strengths. The Wholesale Acquisition Cost for a 12-week supply of 90 mg is $985 and the WAC for a 12-week supply of 45 mg is $575. The biosimilar is available at this low, transparent price to CivicaScript's members and partners, including health plans and pharmacy benefit managers."

Biosimilar launch • Pricing • Crohn's disease • Psoriasis • Psoriatic Arthritis • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus • Ulcerative Colitis

Effect of Glp-1 and Antidiabetic sgLT2 Agents for myoCardial infarcTion and Ultrasensitive Inflammatory Surveillance (GALACTUS Trial) (clinicaltrials.gov) - P3 | N=44 | Recruiting | Sponsor: Instituto Mexicano del Seguro Social | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Congestive Heart Failure • Myocardial Infarction

Effect of Glp-1 and Antidiabetic sgLT2 Agents for myoCardial infarcTion and Ultrasensitive Inflammatory Surveillance (GALACTUS Trial) (clinicaltrials.gov) - P3 | N=44 | Not yet recruiting | Sponsor: Instituto Mexicano del Seguro Social

New P3 trial • Cardiovascular • Congestive Heart Failure • Myocardial Infarction

Real World Conversion from NPH to Insulin Glargine-yfgn in an Outpatient Clinic Setting (ASHP 2025) - No abstract available

Clinical • Real-world • Real-world evidence

Insulin Glargine Utilization and Spending Before and After the First Biosimilar Insulin Glargine: A Real-World Data Study. (PubMed, J Gen Intern Med) - "Basaglar® release was associated with spending reductions that accelerated after Semglee® availability. Biosimilar availability was associated with increases in glargine users and users per fixed-dollar amount. This study provides supportive evidence for biosimilar adoption policies."

Journal • Real-world evidence • Diabetes • Metabolic Disorders

Assessing the Value of Biosimilars: A Cost-Effectiveness Approach for Managed Care Organizations. (PubMed, J Pharm Pract) - "Biologics included Humira, Remicade, and Lantus, with biosimilars Cyltezo, Avsola, and Semglee. Pharmacists can help lead biosimilar use through counseling and substitution protocols. Greater alignment between clinical evidence and formulary practices can lower costs, improve access, and promote sustainable care."

HEOR • Journal • Crohn's disease • Diabetes • Gastroenterology • Immunology • Inflammatory Arthritis • Inflammatory Bowel Disease • Metabolic Disorders • Rheumatoid Arthritis • Rheumatology • Type 1 Diabetes Mellitus

Improved Insurance Coverage Increased Biosimilar Semglee's Market Share After The FDA's Interchangeability Designation. (PubMed, Health Aff (Millwood)) - "Semglee is a biosimilar for Lantus (insulin glargine), the most-prescribed long-acting insulin in the US. These results suggest that increased adoption was mediated mainly through improved insurance coverage, with no detectable role for increased prescribing alone and only a secondary role, at most, for pharmacist substitution. Semglee's gains in market share after interchangeability suggest that easing of federal interchangeability requirements may moderately spur biosimilar adoption."

FDA event • Journal • Reimbursement • US reimbursement

Post-marketing safety of Lantus and its interchangeable biosimilar Semglee in the United States: A disproportionality analysis using the FDA Adverse Event Reporting System (FAERS) database. (PubMed, Diabetes Obes Metab) - "Findings identified significant post-marketing safety signals of Lantus and Semglee. Longitudinal studies are warranted to verify these signals."

Adverse events • Journal • P4 data • Diabetes • Hypoglycemia • Lipodystrophy • Metabolic Disorders

Afrezza® INHALE-1 Study in Pediatrics (clinicaltrials.gov) - P3 | N=319 | Completed | Sponsor: Mannkind Corporation | Active, not recruiting ➔ Completed

Trial completion • Diabetes • Metabolic Disorders • Pediatrics • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

Prescription Dispensing for Insulin Glargine After Interchangeable Biosimilar Designation. (PubMed, JAMA Health Forum) - "To assess impacts of the transition of Semglee to interchangeable designation on prescription dispensing...In this economic evaluation, the first US Food and Drug Administration approval of interchangeable status was associated with increased dispensing of the follow-on. This suggests that interchangeability designation may play an important role in decreasing costs and increasing access to biosimilar prescription drugs for patients."

Journal

An open-label, multiple ascending dose trial of orally administered insulin Tregopil in patients with type 1 diabetes mellitus to evaluate its pharmacokinetics, pharmacodynamics, safety and tolerability. (PubMed, Diabetes Obes Metab) - P1 | "Fixed-dose insulin Tregopil reduced the requirement for insulin aspart supplementation, although it was not a viable stand-alone option for the daily management of T1DM. Insulin Tregopil could be explored with a flexible dosing approach and be titrated based on individual needs."

Journal • PK/PD data • Diabetes • Hypoglycemia • Metabolic Disorders • Type 1 Diabetes Mellitus

State Substitution Laws and Uptake of an Interchangeable Insulin Biosimilar. (PubMed, JAMA Health Forum) - "This retrospective cohort study using MarketScan commercial claims data examined fills for insulin glargine among users who were younger than 65 years and had fills for the insulin glargine Lantus (Sanofi) and its biosimilars, interchangeable insulin glargine-yfgn (Semglee [Mylan Pharmaceuticals]) and a noninterchangeable insulin glargine (Basaglar [Lilly]). Three restrictions had more pronounced associations with a lower uptake of insulin glargine-yfgn: enhanced physician notification (-8.15 pp; 95% CI, -12.49 to -3.81 pp; P < .001), refill notifications (-4.68 pp; 95% CI, -8.78 to -0.58 pp; P = .03), and patient notification (-3.52 pp; 95% CI, -8.44 to 1.40 pp; P = .16). In this cohort study, insulin users in states with less restrictive substitution laws were more likely to fill the biosimilar alternative to insulin glargine, underscoring the role of state regulations of substitution as an important determinant of biosimilar adoption and the need for reforms to..."

Journal • Retrospective data

What do the guidelines say about use of biosimilar insulin therapy? Simple practical considerations to guide clinicians in different patient subgroups-Sharing Canadian perspectives. (PubMed, Diabetes Obes Metab) - "This review article intends to review the efficacy and safety data from pivotal clinical trials with biosimilar insulins, as well as the regulatory and health economic considerations which underpin the safe and cost-effective use of biosimilar insulin therapy. Biosimilars are not the same as generic medications. Generic medication contains identical ingredients to the reference, whereas biosimilar medication is highly comparable but not necessarily identical to the reference. There are five biosimilar insulins currently available in Canada: insulin glargine (U-100) as the biosimilar insulins, Basaglar® and Semglee®, insulin lispro (U-100) as the biosimilar insulin, Admelog® and insulin aspart (U-100) as the biosimilar insulins, Trurapi® and Kirsty™. Data for biosimilars must be submitted in a stepwise approach to demonstrate similarity to the reference biologic under the following categories: structure & function, human clinical trials,..."

Journal • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

Role of biosimilar introduction on insulin glargine prices: a retrospective analysis in 28 European countries. (PubMed, BMJ Open) - "This is the first study to show the price trend of insulin glargine and its correlation with the introduction of biosimilars, in Europe. A significant price reduction of the originator was observed after biosimilars entered the market. The median cost of biosimilars was lower than the originator, although with substantial differences between individual countries and producers."

Journal • Retrospective data

Blood Glucose Management Using Insulin Glargine Lantus Versus the Biosimilar Insulin Glargineyfgn (ASHP 2024) - No abstract available

RCT Glargine vs NPH for Treatment of DM in Pregnancy (clinicaltrials.gov) - P3 | N=160 | Recruiting | Sponsor: Loyola University

New P3 trial • Diabetes • Gestational Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Insulin Access Enhancement in India: Expert Views on Integrating Interchangeable Biosimilar Insulin Glargine. (PubMed, Cureus) - "The 'interchangeability' designation by the United States Food and Drug Administration (USFDA) elevates the biosimilar concept, promoting faster and broader adoption of insulin biosimilars, especially benefiting patients prone to non-adherence to insulin therapy. Healthcare providers are encouraged to consider the option of initiating or transitioning to biosimilar insulin glargine to address the insulin accessibility challenges."

Journal • Review • Diabetes • Metabolic Disorders

Readmission Within 24 Hours of Discharge in a Patient with Type 1 Diabetes: A Need for Practical Guidance and Further Research (ENDO 2024) - "Three discharge prescriptions were sent to a local pharmacy including an insulin glargine pen (22 units), insulin glargine-yfgn pen (24 units), and insulin lispro pen...Hospital bedside medication delivery programs and electronic health record diabetes specific discharge order sets are potential strategies to improve discharge medication accuracy and access. Further research is needed on the impact of these strategies on hospital readmission rates in patients with diabetes."

Clinical • Autism Spectrum Disorder • Bipolar Disorder • CNS Disorders • Diabetes • Genetic Disorders • Metabolic Disorders • Mood Disorders • Psychiatry • Type 1 Diabetes Mellitus

Afrezza® INHALE-1 Study in Pediatrics (clinicaltrials.gov) - P3 | N=319 | Active, not recruiting | Sponsor: Mannkind Corporation | Recruiting ➔ Active, not recruiting | Trial primary completion date: Feb 2024 ➔ Sep 2024

Combination therapy • Enrollment closed • Trial primary completion date • Diabetes • Metabolic Disorders • Pediatrics • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

Early Administration of Insulin Glargine in Patients With Diabetic Ketoacidosis (clinicaltrials.gov) - P2 | N=8 | Terminated | Sponsor: HealthPartners Institute | N=150 ➔ 8 | Trial completion date: Feb 2024 ➔ Feb 2023 | Recruiting ➔ Terminated | Trial primary completion date: Dec 2023 ➔ Feb 2023; Study intervention was adopted as standard of care.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Metabolic Disorders

Afrezza® INHALE-1 Study in Pediatrics (clinicaltrials.gov) - P3 | N=264 | Recruiting | Sponsor: Mannkind Corporation | Trial completion date: Apr 2024 ➔ Apr 2025

Combination therapy • Trial completion date • Diabetes • Metabolic Disorders • Pediatrics • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus