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

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

Biocon Biologics Concludes Integration of Acquired Biosimilars Business in ~120 countries (Biocon Press Release) - "Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd...announced the successful completion of the transition of the acquired biosimilars business in ~120 countries across Advanced and Emerging Markets, a year ahead of schedule....All Viatris’ biosimilar brands, including...Hulio® (bAdalimumab), Nepexto® (bEtanercept), Semglee® (bGlargine)...will now be marketed by Biocon Biologics teams, ensuring business continuity for patients, prescribers, partners, and healthcare systems."

M&A • Crohn's disease • Diabetes • Immunology • Inflammatory Bowel Disease • Metabolic Disorders • Psoriasis • Ulcerative Colitis

Evaluation of Insulin Glargine-yfgn in Veterans for the Treatment of Type II Diabetes Mellitus at the Providence Veterans Affairs Medical Center (ASHP 2023) - No abstract available

Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Afrezza® INHALE-1 Study in Pediatrics (clinicaltrials.gov) - P3 | N=264 | Recruiting | Sponsor: Mannkind Corporation | Trial primary completion date: Aug 2023 ➔ Dec 2023

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

Diabetic Ketoacidosis due to Non-Medical Switching (ENDO 2023) - "Both her standing prescription for long-acting (Basaglar, Eli Lilly and Company, Indianapolis, IN, USA) and rapid-acting (Admelog, sanofi-aventis U.S. LLC, Bridgewater, NJ, USA) insulin were no longer covered. The insulin treatment was switched as requested by her health insurance and Semglee (Mylan Pharmaceuticals Inc., a Viatris Company, Morgantown, WV, USA) as long-acting and Humalog (Eli Lilly and Company, Indianapolis, IN, USA) as rapid-acting insulin prescriptions were transmitted to the pharmacy electronically...Even if Admelog was prescribed, she was under the impression that she was getting her rapid-acting insulin needs from Semglee...Abstracts presented at a news conference are embargoed until the date and time of the news conference. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO.*"

Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Afrezza® INHALE-1 Study in Pediatrics (clinicaltrials.gov) - P3 | N=264 | Recruiting | Sponsor: Mannkind Corporation | Trial primary completion date: Apr 2023 ➔ Aug 2023

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

In Brief: Rezvoglar - another insulin glargine product interchangeable with Lantus. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal

Comparative clinical efficacy and safety of insulin glargine 300 U/mL (Toujeo) versus insulin glargine 100 U/mL in Type 2 and Type 1 diabetes mellitus: A systematic literature review and meta-analysis. (PubMed, Diabetes Obes Metab) - "Gla-100 and Gla-300 had comparable efficacy and safety profiles in both T1D and T2D populations. Gla-300 showed a lower risk of nocturnal and total hypoglycemia, significant in insulin-experienced/exposed patients with T2D. Patients on Gla-300 required significantly more units of insulin daily than the Gla-100 group to achieve equivalent efficacy."

Journal • Retrospective data • Review • Diabetes • Hypoglycemia • Metabolic Disorders • Type 1 Diabetes Mellitus

Efficacy and safety of Tregopil, a novel, ultra-rapid acting oral prandial insulin analog, as part of a basal-bolus regimen in type 2 diabetes: a randomized, active-controlled phase 2/3 study. (PubMed, Expert Opin Pharmacother) - P2/3 | "Efficacy and safety of ultra-rapid acting oral prandial insulin Tregopil was compared with insulin aspart (IAsp) in patients with type 2 diabetes (T2D) on insulin glargine and metformin...While Tregopil's early postprandial effects were comparable to IAsp, its late postprandial effects were inferior. The trial is registered at ClinicalTrials.gov (CT.gov identifier: NCT03430856)."

Journal • P2/3 data • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Immunogenicity, Efficacy, and Safety of Biosimilar Insulin Aspart (MYL-1601D) Compared with Originator Insulin Aspart (Novolog) in Patients with Type 1 Diabetes After 24 Weeks: A Randomized Open-Label Study. (PubMed, BioDrugs) - P3 | "MYL-1601D demonstrated similar immunogenicity, efficacy, and safety profiles to Ref-InsAsp-US in patients with T1D over 24 weeks. CLINICAL TRIAL REGISTRATION CLINICALTRIALS.GOV: NCT03760068."

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

Biosimilars and interchangeable biosimilars: facts every prescriber, payor, and patient should know. Insulins perspective. (PubMed, Expert Opin Biol Ther) - "Biocon-Viatris's biosimilar Insulin Glargine (Semglee®) is the first interchangeable biosimilar insulin approved by the US FDA. The 'interchangeable' status can prompt faster and wider uptake of insulin biosimilars and keep the insulin expenditure under control, especially for patients who otherwise practice non-adherence or rationing of life-saving insulin. Education, support, and awareness can ensure that interchangeable biosimilars gain wider acceptance."

Journal • Diabetes • Metabolic Disorders

Mylan Insulin Glargine Study (clinicaltrials.gov) - P3 | N=219 | Completed | Sponsor: Mylan Inc. | Active, not recruiting ➔ Completed

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