As brand-name insulins that have dominated the market continue going off patent, new "biosimilar" versions are poised to shake up the diabetes world. And now... Hello, generic meal-time insulin!

This week, Sanofi launched its new meal-time insulin Admelog, basically a copycat version of Lilly's Humalog that's been around for more than two decades now. The FDA had approved Admelog in December 2017, and now about four months later Sanofi has announced it's available in U.S. pharmacies at the "lowest list price" of any meal-time insulin on the market.

Here are the two press releases issued on Admelog, from the FDA and by Sanofi., when it was first approved on Dec. 11, 2017.

The regulatory approval came two years after approval of the first-ever so-called "follow-on" insulin, Eli Lilly's long-acting Basaglar, that is a copycat version of Lantus. That new basal insulin hit the market a year later in December 2016, dealing a blow to Sanofi in that even before it was available, payers began including it in their insurance formularies to replace Lantus.

The notion of generics always sparks hope and excitement among the Diabetes Community about "a more affordable option" (in Sanofi's own words) to ever-pricier insulin products. Yet initially, Sanofi did not provide pricing details.

Now that Sanofi's announced the official launch of Admelog, they've released pricing information, along with a savings program for both this new insulin and also its long-acting Lantus basal insulin. More on that shortly, but first the 411 on Ademlog...

 

Admelog Insulin Specifics

Who and How? This first "copycat" version of Humalog has been FDA approved for adults with type 2, and anyone 3 years or older with type 1 diabetes. It will be sold in 10mL, 100-unit vials and in the prefilled SoloStar insulin pens, and can be used in insulin pumps as well intravenously in hospitals.

Is It Generic? Well, the technicalities of using that term invoke a high-level, academic distinction that doesn't really mean anything for most of us lay-folks. We're in the early stages of the long-awaited era of biosimilars (even if they aren't technically called that by U.S. regulatory leaders), that are basically similar versions of already-approved insulins that bring with them the potential for lower prices.

To be clear, this is a whole new world of insulin products different from anything we've seen before. We’re not talking about those Walmart "generic" insulins that are just cheap forms of older-gen products like R, N, and 70/30 mix, simply sold under Walmart’s ReliOn brand name. In contrast, these new biosimilar “generics” are actually novel formulations that copy the biological molecule of an existing insulin.

How Fast Is It? As a copy of Humalog, Admelog has a similar curve of action. The label "short-acting" is of course used to differentiate the meal-time (bolus) insulin category from long-acting types of (basal) insulin, such as Basaglar/ Lantus/ Levemir, and older versions.

FDA Fostering Low Costs: The FDA approved Admelog through a streamlined pathway under which companies can rely on the FDA's previous approval of a similar drug already deemed safe and effective, or on previously published literature supporting safety and/or effectiveness. This process is meant to reduce drug development costs to in turn reduce the drug's price.

Interesting Note: the FDA gave Admelog tentative approval in September, but delayed the final OK until competitor Lilly had time to challenge Sanofi over patents; that didn't happen during the 45-day window (according to a Sanofi earnings report), and this full approval now follows.

FDA Commissioner Scott Gottlieb said in a statement: "One of my key policy efforts is increasing competition in the market for prescription drugs and helping facilitate the entry of lower-cost alternatives. This is particularly important for drugs like insulin that are taken by millions of Americans every day for a patient's lifetime to manage a chronic disease."

 

So What Does Admelog Cost?

Sanofi wasn't originally saying, at the time of FDA approval. Their spokes-folks remind us that it's not uncommon to withhold pricing details until launch, and they point to Sanofi's pricing principles announced in May 2017 that state the company wouldn't raise prices more than the medical inflation rate (or 5.4% for last year).

When launched on April 5, 2018, Sanofi's Admelog came in at the price point of:

  • $233 per 10mL vial
  • $450 per box of five 3mL insulin pre-filled pens (or $90 per pen -- though you can't order individually)

By comparison, Humalog's list price is set at $275 per vial and $530 for a box of five prefilled KwikPens, though often the cash price is higher at local pharmacies (i.e. $325 per vial and $702 per box at Walgreens). 

That makes Admelog roughly 15% less expensive than Humalog at this time, when based on those Pharma-supplied figures.

This is pretty much equivalent to the saving we saw with Lilly's "follow-on" basal insulin Basaglar when it was launched at the end of 2016 -- its cash price started out 15% less expensive than Lantus and at the end of 2017 was roughly 18.6% less than its brand name counterpart.

 

Insulin Pricing Outrage

Of course, a lot has changed in the past two years in the context of drug pricing and insulin pricing specifically.

There's been an unprecedented, growing drumbeat of anger and public pressure -- by the media, the general public, Congress members and within our D-Community. Insulin manufacturers (Sanofi included) are being sued in federal court on allegations of price-fixing, #insulin4all protests are being organized nationwide, and Congressional members are now calling out Pharma, Pharmacy Benefit Managers (PBMs) and insurance companies over their practices that inflate insulin prices.

Coincidentally, in the same week Sanofi was announcing this Admelog approval a Congressional committee was holding the next in a series of drug pricing hearings, and insulin prices came up many times.

Pressed on this affordability issue, Sanofi has also announced a discount "VALyou" program for both Admelog and Lantus insulins -- though eligibility varies and those on federal programs such as Medicare/ Medicaid are not eligible. This would apply to those who are uninsured or on high-deductible plans where deductibles aren't met, or anyone willing to bypass their insurance coverage when buying this insulin. A savings card will be provided, which can be used for one prescription every 12 months:

  • $99 for a 10mL vial of Admelog or Lantus
  • $149 for a box of 5 pre-filled Admelog or Lantus pens
  • Patients can "re-register" once the savings card expires
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“We understand that many people living with diabetes struggle to afford critically needed medications, especially those facing high out-of-pocket costs when paying for their insulin,” says Sanofi's head of North America Diabetes and Cardiovascular Divisions, Michelle Carnahan. “This program helps support those we can today, while we continue to innovate to help even more people tomorrow. It is our goal to do our part to find ways that help people living with diabetes gain access to insulins they need to help manage their disease, at a clear and consistent price, regardless of their pharmacy choice.”

While these savings programs are controversial and their days may be numbered, these discount options do offer financial relief to those paying full out-of-pocket prices for insulin -- something that's more and more common these days.

 

Wait, What About Apidra?

Finally, don't forget that Sanofi already has a short-acting (mealtime) insulin in its portfolio: Apidra, which some say has a quicker peak action time than both competitors on the market, Humalog and Novolog, and has been available since 2004.

Some may wonder if Sanofi is cannibalizing its own product, by now selling another short-acting insulin that isn't too different but may cost less?

Sanofi tells us they will "continue to invest in Apidra" with a goal of serving the most people as possible with these two choices.

Still, we understand it's been a tough go for Apidra -- as many payers (insurance providers) don't don't cover it adequately (or at all) and some PWDs have experienced problems using it in insulin pumps. It's almost viewed as the red-headed stepchild compared to the other mainstream brands. Now with Admelog, Sanofi may be able to become more competitive with a lower-cost option -- assuming that turns out to be the case for most PWDs.

As always, the proof will come when the rubber hits the road in the real world of peoples' lives.