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

On Dec. 11, the first short-acting insulin of this type was approved by FDA. Called Admelog and made by Sanofi, it’s basically a copycat version of Lilly’s Humalog, which was first sold here in the U.S. more than two decades ago.

Admelog is expected to launch at some point in “early 2018” according to Sanofi. Here are the two press releases issued on Admelog, from the FDA and by Sanofi.

This comes two years after approval of the first so-called “follow-on” insulin, long-acting Basaglar from Lilly, 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.

But given that Sanofi has not yet provided any pricing details, especially compared to its direct competitor Humalog, there’s no way of knowing just how affordable this drug will be when it launches early next year.


Admelog Specifics

First, some specifics about Admelog itself:

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 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 with diabetes. 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? As a copy of Humalog, Admelog has a similar curve of action. The label “short-acting” is of course used to differentiate this mealtime insulin category from long-acting types of basal insulins, such as Basaglar/ Lantus/ Levemir, and older versions.

FDA Fostering Low Costs: The FDA approved Admelog through an abbreviated approval pathway under which companies can rely on the FDA’s previous approval of a drug as safe and effective or on previously published literature supporting safety and/or effectiveness. This process is meant to reduce drug development costs in order to reduce the drug’s price on the market — so let’s hope that happens!

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.

“One of my key policy efforts is increasing competition in the market for prescription drugs and helping facilitate the entry of lower-cost alternatives,” FDA Commissioner Scott Gottlieb said in a statement. “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.”


What About Apidra?

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.


Insulin Pricing and Access

Here’s where the rubber meets the road, or at least what matters most when it comes to follow-on insulin versions like Admelog: Just how much is this going to cost?

Sanofi is not yet saying. Their spokes-folks remind us that it’s not uncommon to withhold pricing details at the time of a product’s regulatory approval, and the company points to Sanofi’s pricing principles announced in May 2017 that say it won’t raise prices more than the medical inflation rate (or 5.4% for this year). Sanofi says it will also disclose the factors that go into its insulin pricing, once those details are spelled out at the time of Admelog’s launch.

Humalog’s cash price currently runs about $325.78 for a 10mL vial and $643.69 for a box of five prefilled pens. The hope is that Admelog will be notably cheaper.

If we look to Lilly’s “follow-on” basal insulin Basaglar for any guidance on this, it may not prove to be very reassuring. Launched a year ago, its cash price started out 15% less expansive than Lantus and it’s now roughly 18.6% less than its brand name counterpart. That company also did not reveal pricing details at the time of FDA approval in December 2015, it waited a full year until the product hit the market.

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

There’s been an unprecedented, growing drumbeat of anger and public pressure over drug prices — 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 have begun being organized, and Pharma’s regularly being called out by Congressional members over their practices that coincide with what Pharmacy Benefit Managers (PBMs) and insurance companies are doing to keep insulin costs high. Coincidentally and very notably, in the same week Sanofi was announcing this Admelog approval a Congressional committee was holding the next in a series of hearings over drug pricing, and insulin prices came up many times.

So the marketing language of a new, “more affordable option” can’t be taken at face value any longer…

We are happy to see this new innovation in insulin, but since the most innovative thing about it is the potential to bring prices down, we can’t get too excited until we see the price tag. Sanofi, the ball is in your court.