On the heels of Viatris and Biocon Biologics’ landmark diabetes copycat Semglee, another interchangeable biosimilar is crashing the infamously pricey insulin market.
Wednesday, the FDA blessed Eli Lilly’s approved insulin simulacrum Rezvoglar with an interchangeability tag, meaning the product can be swapped out for its brand-name counterpart right at the pharmacy counter. Biosimilar interchangeability has been touted for its potential to improve drug access to high-cost biologics by offering alternatives at competitive prices.
Like Semglee, Lilly’s Rezvoglar—which was first approved in December 2021—references Sanofi’s blockbuster diabetes drug Lantus.
It isn’t immediately clear what sort of role Lilly's biosimilar will play, or whether the new approval designation will lead to a price tag adjustment. The "[p]rice and availability of Rezvoglar are to be determined," a Lilly spokesperson said over email.
As a reference point, Sanofi’s brand name Lantus runs a little over $300 out of pocket for a 10-ml supply, according to public sources.
Meanwhile, pharmaceutical pricing dynamics drove a unique strategy behind Semglee’s launch. After approval, Viatris rolled out two versions to help the product navigate the tricky insulin market.
Semglee debuted in both a branded and unbranded format, with respective wholesale acquisition costs (WACs) of $404 and $147.98 per package of five 3-ml pens, Viatris told Fierce Pharma last year. The WAC for the unbranded version, simply dubbed insulin glargine, was around 65% cheaper than Lantus’ list price when it debuted in 2021, a Viatris spokesperson noted.
In essence, Viatris offered payers the option between a high-price, high-rebate product, or a lower-price, lower-rebate alternative, former Bernstein analyst Ronny Gal explained in a note to clients at the time.
But Viatris won’t be able to rely on Semglee much longer. Back in February, Biocon said it would pay about $3.34 billion to snap up its partner’s entire biosimilars business. Earlier this week, Biocon chair and managing director Kiran Mazumdar-Shaw told the company’s BioConversations blog the acquisition “is expected to close shortly.”
Industry-wide, it remains to be seen if interchangeable biosimilars can truly make a dent in the insulin market. Aside from public and political pressure, diabetes drugmakers themselves are now calling for the need to control the medicine’s cost.
Speaking at the STAT Summit 2022 this week, Eli Lilly CEO Dave Ricks said that in light of the company’s recent ‘free insulin’ Twitter fiasco, “we have more work to do to bring down the cost of insulin for more people.”
Even as lawmakers work to counter high insulin costs, the current situation remains bleak for some patients. According to a recent study from the Annals of Internal Medicine, more than 1 million adults in the U.S. have to ration their insulin because of the current pricing landscape.
Next year will likely bring some relief, however, as the Inflation Reduction Act is set to cap out-of-pocket insulin costs to $35 a month for patients on Medicare.
Editor's note: This story has been updated with comments from Eli Lilly.