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.
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.
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.