Admelog Insulin: Lispro Biosimilar to Humalog

Medical Disclaimer

This article is for informational purposes only and does not constitute medical advice. Always consult your physician or a qualified healthcare provider regarding any medical condition or treatment.

Key Takeaways

  • Admelog is Sanofi's insulin lispro, FDA-approved in 2017 as a follow-on biologic (biosimilar) to Humalog with the same active molecule and similar clinical effect.
  • It is approved for adults and children age 3 and older with type 1 (T1D) and type 2 (T2D) diabetes via vial, SoloStar pen, or insulin pump.
  • Switching from Humalog to Admelog is dose-equivalent, but always check with your prescriber and pharmacist before substituting.
  • Talk with your insurance plan about formulary status — Admelog is often less expensive than Humalog and may be the preferred lispro on your plan.

Admelog (insulin lispro) is Sanofi’s mealtime insulin, approved by the FDA in December 2017 as a follow-on biologic to Eli Lilly’s Humalog. It contains the same insulin lispro molecule and produces clinically similar glucose-lowering effect. Admelog is approved for adults and children age 3 and older with type 1 (T1D) and type 2 (T2D) diabetes and is available in U-100 vials, SoloStar prefilled pens, and for use in insulin pumps.

What “Follow-On Biologic” Means

Insulin is a complex biologic molecule, and until 2020 it was approved through the older 505(b)(2) pathway in the United States rather than the formal biosimilar pathway used for monoclonal antibodies. Admelog was approved as a follow-on biologic — clinically equivalent to Humalog but not formally designated “interchangeable” until later regulatory transitions. In practice, prescribers and pharmacists treat Admelog as a biosimilar to Humalog at a one-to-one dosing ratio.

Pharmacology Overview

Parameter Admelog (insulin lispro)
Class Rapid-acting insulin analog
Active ingredient Insulin lispro
Concentration U-100
Onset ~15 minutes
Peak 30 minutes to 2.5 hours
Duration 3-6.5 hours
Mealtime window 15 minutes before to immediately after meal
Available forms 10 mL vials, 3 mL SoloStar pens, pump use
Approved age 3 years and older

Approved Uses

Admelog is FDA-approved to improve glycemic control in:

  • Adults with T1D and T2D.
  • Children age 3 and older with T1D.
  • Subcutaneous injection by vial-and-syringe or SoloStar pen.
  • Continuous subcutaneous insulin infusion via insulin pump.
  • Intravenous administration in healthcare settings (less commonly used).

Switching From Humalog to Admelog

Most people switching between Humalog and Admelog do so at a one-to-one ratio with no dose change required. Things to confirm before switching:

  • Your prescriber and pharmacist agree on the substitution and update labels.
  • Your insulin pump or pen is compatible with the new product.
  • You monitor blood glucose closely for the first 1-2 weeks to catch unexpected differences.
  • You retain a pen or vial of the original product as backup until the switch is settled.

Children, pregnant women, and people with brittle T1D or hypoglycemia unawareness should switch only under direct clinical supervision.

Side Effects

  • Hypoglycemia — the most common and dangerous adverse effect of any rapid-acting insulin.
  • Injection site reactions — redness, itching, lipohypertrophy with site reuse.
  • Weight gain — common to all insulin therapy, typically modest.
  • Hypokalemia — relevant in hospitalized or high-dose use.
  • Allergic reactions — rare with modern lispro formulations.
  • Antibody formation — minor and clinically insignificant in most patients.

Cost and Insurance Access

Admelog launched with a deliberate pricing strategy designed to capture market share from Humalog by offering lower net prices to insurers and pharmacy benefit managers. The Sanofi Insulins Valyou Savings Program has offered Admelog at roughly $99 cash per box of pens or vial set. Many insurance formularies prefer Admelog over Humalog for cost reasons — meaning Admelog may have a lower copay or be the only lispro covered.

The federal $35 monthly Medicare insulin cap and similar manufacturer programs apply to Admelog. Always check current pricing with your pharmacy.

Storage and Handling

Unopened Admelog vials and pens belong in the refrigerator at 36-46 degrees F. Once in use, they last up to 28 days at room temperature (below 86 degrees F). Never freeze Admelog and never expose it to direct sunlight or extreme heat. Inspect before each dose — Admelog should be clear and colorless; discard any that is cloudy, discolored, or contains particles.

Where Admelog Fits in Diabetes Care

Admelog is a mealtime (prandial) insulin used in basal-bolus regimens for T1D and insulin-requiring T2D, often paired with long-acting insulins like Lantus, Tresiba, Toujeo, or Basaglar. It is also a common pump insulin. For people newly diagnosed with prediabetes or early T2D, mealtime insulin is rarely needed — focus on the strategies in our treatment hub and track progress with the A1C test.

The Bottom Line

Admelog is a follow-on biologic of insulin lispro that delivers the same mealtime glucose control as Humalog at a typically lower price. It is approved for vial, pen, and pump use in adults and children age 3 and older. Switching from Humalog is dose-equivalent in most cases, but should be coordinated with your prescriber and pharmacist. Cost savings can be meaningful, particularly if your insurance plan prefers Admelog on its formulary.

Frequently Asked Questions

Is Admelog the same as Humalog?

Admelog contains the same active ingredient — insulin lispro — as Humalog and produces clinically similar glucose lowering. It is approved as a follow-on biologic (biosimilar in clinical practice), not a true generic. Switching is generally dose-equivalent but should be confirmed with your prescriber and pharmacist for your specific situation.

Can Admelog be used in an insulin pump?

Yes. Admelog is FDA-approved for continuous subcutaneous insulin infusion in pumps. Many pump users switch from Humalog to Admelog without dosing changes. As with any pump insulin, monitor for unexplained high readings or set occlusions and rotate sites at each set change.

How much does Admelog cost compared to Humalog?

List prices are typically similar, but Sanofi launched Admelog with discounting designed to undercut Humalog's net price by roughly 30 to 40 percent. Actual out-of-pocket cost depends on your insurance formulary. The Admelog Insulins Valyou Savings Program has offered cash prices around $99 per box of pens or vial set.

Sources

  1. U.S. Food and Drug Administration. Admelog (insulin lispro) Prescribing Information, 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/
  2. Garg SK et al. Efficacy and Safety of Insulin Lispro (SAR342434) Compared with US-Approved Humalog. Diabetes Obes Metab. 2017;19(11):1568-1575.
  3. Sanofi. Admelog Product Information. https://www.admelog.com