Merilog (insulin-aspart-szjj) / Sanofi - LARVOL DELTA

In brief: Merilog - a NovoLog biosimilar. (PubMed, Med Lett Drugs Ther) - No abstract available

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

FDA Approves First Rapid-Acting Insulin Biosimilar Product for Treatment of Diabetes (PRNewswire) - "Today, the U.S. Food and Drug Administration approved Merilog (insulin-aspart-szjj) as biosimilar to Novolog (insulin aspart) for the improvement of glycemic control in adults and pediatric patients with diabetes mellitus. Merilog, a rapid-acting human insulin analog, is the first rapid-acting insulin biosimilar product approved by the FDA. As a rapid-acting insulin, Merilog helps to lower mealtime blood sugar spikes to improve control of blood sugar in people with diabetes. The approval is for both a 3 milliliter (mL) single-patient-use prefilled pen and a 10 milliliter (mL) multiple-dose vial."

FDA approval • Diabetes

Safety and Efficacy of Switching SAR341402 Insulin Aspart and Originator Insulin Aspart vs Continuous Use of Originator Insulin Aspart in Adults With Type 1 Diabetes: The GEMELLI X Trial. (PubMed, J Diabetes Sci Technol) - "SAR341402 insulin aspart (SAR-Asp) is a rapid-acting insulin analog developed as an interchangeable biosimilar to the marketed insulin aspart reference product (NovoLog; NN-Asp)...This report assessed whether multiple switches between SAR-Asp and NN-Asp lead to equivalent safety and efficacy compared with continuous use of NN-Asp in adults with type 1 diabetes (T1D) treated with multiple daily injections, using once-daily insulin glargine U100 (Lantus) as the basal insulin...Alternating doses of SAR-Asp and NN-Asp compared with continuous use of NN-Asp showed similar safety, immunogenicity, and clinical efficacy in adults with T1D. This study supports interchangeability between SAR-Asp and NN-Asp in T1D management."

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

Pharmacokinetic similarity of switching SAR341402 insulin aspart biosimilar and NovoLog insulin aspart versus continuous use of NovoLog in adults with type 1 diabetes: The GEMELLI X trial. (PubMed, Diabetes Obes Metab) - "PK exposure of SAR-Asp (switching group) and reference NN-Asp (non-switching group) were similar, supporting interchangeability between these two insulin aspart products."

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

In vitro stability of biosimilar insulin aspart SAR341402 in the Medtronic MiniMed insulin pumps: Running title: Similarity of insulin aspart products in simulated CSII (48 characters). (PubMed, J Pharm Sci) - "Leachable profiles from pump and reservoir samples were similar in all product batches. Like NovoLog®/NovoRapid®, SAR341402 demonstrates appropriate physicochemical stability when used in these insulin pump systems."

Journal • Preclinical • Diabetes • Metabolic Disorders

Pharmacokinetic Similarity between Biosimilar Insulin Aspart Premix SAR341402 Mix 70/30 and Originator Insulin Aspart Mix 70/30 (NovoMix 30) in Indian Adults with Type 2 Diabetes: GEMELLI M Substudy. (PubMed, Indian J Endocrinol Metab) - "Other efficacy endpoints, insulin dosages, anti-insulin aspart antibody response, hypoglycemia and adverse events were similar between groups. Our results support the findings from previous studies, that SAR-Mix has a similar pharmacokinetic profile to NN-Mix and provides effective glycemic control with similar safety and immunogenicity profile in Indian adults with type 2 diabetes."

Journal • PK/PD data • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy, Safety, and Immunogenicity of Biosimilar Insulin Aspart Premix SAR341402 Mix 70/30 Compared with Originator Insulin Aspart Mix 70/30 in Adults with Diabetes (GEMELLI M): A Subgroup Analysis by Prior Type of Premix Insulin. (PubMed, Diabetes Ther) - "Efficacy, safety, and immunogenicity profiles of SAR-Mix are similar to NN-Mix over 26 weeks in adults with diabetes irrespective of prior type of premix insulin."

Journal • Diabetes • Hypoglycemia • Immunology • Metabolic Disorders • Type 2 Diabetes Mellitus

Biosimilar Insulin Aspart Premix SAR341402 Mix 70/30 Versus Originator Insulin Aspart Mix 70/30 (NovoMix 30) in People with Diabetes: A 26-Week, Randomized, Open-Label Trial (GEMELLI M). (PubMed, Diabetes Ther) - "The totality of evidence indicates that SAR-Mix provides effective glycemic control with a similar safety and immunogenicity profile to NN-Mix in people with diabetes treated for 26 weeks."

Journal • Diabetes • Hypoglycemia • Infectious Disease • Metabolic Disorders • Novel Coronavirus Disease • Type 2 Diabetes Mellitus

Pharmacokinetic and pharmacodynamic similarity between SAR341402 insulin aspart and Japan-approved NovoRapid in healthy Japanese subjects. (PubMed, Sci Rep) - "Both treatments were well tolerated. We concluded that similar pharmacokinetic exposure and glucodynamic potency were shown for SAR341402 and NovoRapid in healthy Japanese males."

Clinical • Journal • PK/PD data

Efficacy, Safety, and Immunogenicity of Insulin Aspart Biosimilar SAR341402 Compared with Originator Insulin Aspart in Adults with Diabetes (GEMELLI 1): A Subgroup Analysis by Prior Type of Mealtime Insulin. (PubMed, Diabetes Ther) - P3 | "Efficacy and safety (including immunogenicity) profiles of SAR-Asp are similar to those of NN-Asp over 52 weeks in adults with diabetes irrespective of prior type of mealtime insulin."

Clinical • Journal • Diabetes • Hypoglycemia • Immunology • Metabolic Disorders • Type 2 Diabetes Mellitus

Single-dose euglycemic clamp study in two cohorts to compare exposure of SAR341402 (insulin aspart) Mix 70/30 to US- and EU-Approved versions of insulin aspart Mix 70/30 and SAR341402 rapid-acting solution in subjects with type 1 diabetes. (PubMed, Diabetes Obes Metab) - P1 | "SAR -Mix demonstrated similar pharmacokinetic exposure to commercially available insulin aspart Mix 70/30 formulations, and a distinct exposure profile compared with SAR-Asp."

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

GEMELLI X: Comparison of SAR341402 to NovoLog in Adult Patients With Type 1 Diabetes Mellitus Also Using Insulin Glargine (clinicaltrials.gov) - P3; N=210; Completed; Sponsor: Sanofi; Active, not recruiting ➔ Completed

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

Safety, Immunogenicity and Glycemic Control of Insulin Aspart Biosimilar SAR341402 Versus Originator Insulin Aspart in People with Diabetes also Using Insulin Glargine: 12-Month Results from the GEMELLI 1 Trial. (PubMed, Diabetes Technol Ther) - "SAR-Asp and NN-Asp demonstrated similar efficacy and safety (including immunogenicity) in people with diabetes over 12 months treatment."

Clinical • Journal

EFFICACY, SAFETY AND IMMUNOGENICITY IN PEOPLE WITH DIABETES ON MDI USING SAR341402 OR INSULIN ASPART TOGETHER WITH BASAL INSULIN GLARGINE (GLA-100): GEMELLI-1 STUDY (ATTD 2020) - P3; "The immunogenicity data and TEAEs in subgroups were also consistent with the overall population (Table). Conclusions SAR341402 was as effective and well tolerated as insulin aspart in people with T1DM or T2DM regardless of the baseline characteristics."

Clinical • Napsin A

Safety and tolerability of insulin aspart biosimilar SAR341402 versus originator insulin aspart (NovoLog®) when used in insulin pumps in adults with type 1 diabetes: A randomized, open-label clinical trial. (PubMed, Diabetes Technol Ther) - "SAR-Asp and NN-Asp were well tolerated and had similar infusion set occlusions over a 4-week period in insulin pump users with T1D."

Clinical • Journal

Single-dose euglycemic clamp study demonstrating pharmacokinetic and pharmacodynamic similarity between SAR341402 insulin aspart and US- and EU-approved versions of insulin aspart in subjects with type 1 diabetes. (PubMed, Diabetes Technol Ther) - P1; "The present study demonstrated similar pharmacokinetic exposure profiles and glucodynamic potency between SAR341402, NovoLog and NovoRapid in subjects with T1D, supporting further clinical evaluation of SAR341402 as a biosimilar/follow-on product."

Clinical • Journal • PK/PD data

Efficacy and safety of insulin aspart biosimilar SAR341402 versus originator insulin aspart in people with diabetes treated for 26 weeks with multiple daily injections in combination with insulin glargine: A randomized, open-label trial (GEMELLI 1). (PubMed, Diabetes Technol Ther) - P3; "SAR-Asp demonstrated effective glycemic control with a similar safety and immunogenicity profile to NN-Asp in people with diabetes treated for 26 weeks."

Clinical • Combination therapy • Journal

GEMELLI X: Comparison of SAR341402 to NovoLog in Adult Patients With Type 1 Diabetes Mellitus Also Using Insulin Glargine (clinicaltrials.gov) - P3; N=184; Recruiting; Sponsor: Sanofi; Trial completion date: Dec 2019 ➔ Jul 2020; Trial primary completion date: Dec 2019 ➔ Jul 2020

Clinical • Trial completion date • Trial primary completion date

Safety Assessment of SAR341402 and NovoLog When Administered through an Insulin Pump (ADA 2019) - P1; "The total number of unexplained hyperglycemia was 329: 154 on SAR-Asp and 175 on NN-Asp.In this study SAR-Asp and NN-Asp were well-tolerated. There was no difference in the safety profiles including ISO, hyperglycemia, hypoglycemia, hypersensitivity and injection site reactions when used in CSII."

Clinical • Late-breaking abstract

Similar Efficacy, Safety, and Immunogenicity in People with Diabetes Using SAR341402 or Insulin Aspart: Gemelli 1 Study (ADA 2019) - "SAR341402 (SAR-Asp) was developed as a biosimilar/follow-on product to rapid-acting insulin NovoLog®/NovoRapid® (NN-Asp).This 6-month randomized, controlled, open-label, phase 3 study compared efficacy and safety of SAR-Asp and NN-Asp in adults with type 1 diabetes (T1D) or type 2 diabetes (T2D) also using insulin glargine (GLA100) as basal insulin. There was no difference in the percentage of patients reporting hypoglycaemia. Immunogenicity and safety profiles (adverse events, hypersensitivity events and injection site reactions) were similar for SAR-Asp and NN-Asp (Table).We conclude that biosimilar/follow-on SAR-Asp is safe, effective and well-tolerated as insulin aspart in adults with T1D or T2D."

Clinical • Late-breaking abstract

Comparative PK and PD of the Rapid-Acting Insulin Aspart Product SAR341402, NovoLog, and NovoRapid in Subjects with T1D (ADA 2019) - "Adverse events were similar for T, R1 and R2. No safety concerns were noted in laboratory, vital signs, or ECG data.In summary, this study demonstrated similar insulin aspart exposure profiles and PD activity for SAR-Asp to NN-Asp-US and NN-Asp-EU and between NN-Asp-US and NN-Asp-EU, rendering SAR-Asp a biosimilar/follow-on product."

Clinical • Late-breaking abstract

Comparison of Exposure and Activity of SAR341402 Mix 70/30 to NovoLog Mix 70/30, NovoMix 30 and SAR341402 Rapid-acting Solution in Patients With Type 1 Diabetes Mellitus (clinicaltrials.gov) - P1; N=52; Completed; Sponsor: Sanofi

Clinical • New P1 trial

GEMELLI X: Comparison of SAR341402 to NovoLog in Adult Patients With Type 1 Diabetes Mellitus Also Using Insulin Glargine (clinicaltrials.gov) - P3; N=184; Recruiting; Sponsor: Sanofi

Clinical • New P3 trial

GEMELLI 1: Comparison of SAR341402 to NovoLog/NovoRapid in Adult Patients With Diabetes Mellitus Also Using Insulin Glargine (clinicaltrials.gov) - P3; N=597; Completed; Sponsor: Sanofi; Active, not recruiting ➔ Completed

Clinical • Trial completion