Lilly to Launch Authorized Generic for Humalog

In reaction to the tumult over high insulin prices, the Food and Drug Administration (FDA) has been firming up its plans for a transition to biosimilar competition for insulin. Lilly, one of the dominant insulin manufacturers in the US, has decided to cut prices through the authorized generic route.

Humalog authorized generic

In this case, a manufacturer that owns a branded product with expiring patents may decide to get the upper hand on the impending competition by launching its own low-cost generic version well before other agents can be marketed. With a so-called authorized generic, the drug company may produce the new version itself or sign a royalty agreement with another manufacturer to secure a share of the profits.

The FDA wants to encourage the entry of new competitive players into the insulin arena to lower costs. However, the first entrants (for insulin glargine) were follow-on biologics, not biosimilars. Follow-on insulins are currently regulated under section 505b2 of the Food, Drug, and Cosmetics Act (which covers small molecules and early biologic compounds), not section 351 of the Public Health Service Act (which covers biologics and biosimilars). The transition to regulation under the Public Health Act is not expected to begin until March 2020.

Eli Lilly announced on March 4 that it will sell Humalog® (insulin lispro) as an authorized generic. The Humalog authorized generic will be sold at a 50% discount to the brand’s wholesale acquisition cost. It will be distributed through its ImClone Systems subsidiary. This does not mean that Humalog will no longer be sold. Instead, it will continue to offer the branded version at its same price (and rebates) to payers who prefer this arrangement. Instead, the authorized generic will be sold directly to patients or others who do not benefit from the rebate revenue.

Lilly stated that the new generic version will be available “as soon as possible.” Some believe that a 50% discount is only a half-step. At $137.35 per vial, it is difficult to believe that a patient with a drug deductible or who is uninsured can easily pay the monthly cost of insulin treatment. Brand manufacturers can partly deflect scrutiny through such actions. However, with the prices of several older and brand new categories of drugs considered too high, pressure will remain on drug makers, law makers, and regulators to further lower costs.

In related biosimilar news…Four US Senators have sent a letter to the FDA to ensure that the transition period does not slow competition for insulin products. One aspect of this was the potential need for prospective makers of 505b2 insulins to have to resubmit their drug applications under the 351(k) biosimilar provisions. This could significantly delay entry into the market.

The Week in Biosimilar News

You know it’s been a pretty desperate week in the biosimilar blogosphere when twitter feeds relate back to articles published in January, rehashes of the US Supreme Court decision in June, or yet another estimate of the savings potentially ascribed to biosimilar use (based on erroneous assumptions). However, there were a few significant tidbits announced last week that are worth reviewing.

First, Biocon announced that the decision to approve its trastuzumab biosimilar (with partner Mylan) has been delayed by the Food and Drug Administration (FDA) 3 months (until December 3, 2017). According to Biocon, this delay was required so that the FDA could “review some of the clarificatory information submitted as part of the application review process.” Clarificatory? Really? Maybe the extra time was needed to translate the application itself.

Second, a survey of 103 US gastroenterologists raised a couple of questions as to how well information about Inflectra®, the biosimilar to Remicade®, is sinking in on the practice level. According to a press release from Spherix Global Insights, cross-category prescribing may be interfering with the uptake of the biosimilar. They state, “not only is the decline [in Remicade prescriptions] attributed to the adoption of infliximab biosimilars, but use of Humira® has also significantly increased, potentially indicating that more ulcerative colitis patients are being placed on Humira to avoid insurance mandates for infliximab biosimilar use.” This limited survey found that more than one-third of gastroenterologists “agree that if a pharmacy or managed care plan advises them to use Inflectra over Remicade, that they are more likely to choose a different TNF-inhibitor altogether.” This is a weird finding, perhaps indicating nothing more than spite for the health plan’s benefit design. Clearly, if the physicians fully considered the evidence, they would be less likely to prescribe in this way. Admittedly, as notable numbers of managed care organizations have not actually mandated Inflectra use at this point in time, we would have to wait to see if this opinion is validated in actual practice.

Finally, Sanofi announced that it had received tentative approval on a follow-on biologic form of insulin lispro (the originator product was Lilly’s Humalog®). Patent issues will have to be resolved before Sanofi can receive final approval and bring this product to the market. The insulin biosimilars are not regulated under the Biologics Price Competition and Innovation Act, but rather under the Hatch–Waxman Act—the application was filed as a 505(b)2 rather than a 351(k) variety. They are transitional products, which will considered under the newer regulations after March 23, 2020. We will detail these lesser-known transitional drug categories in a future post.