Biosimilar Endocrinology Roundup: August

August saw notable developments in the market for insulins in the world of endocrinology biosimilars and follow-ons: new studies showed similarity between a challenger to branded insulin glargine; price competition gained momentum; and patients, providers, and state governments signaled an urgent need for diabetes drug prices to drop.

Studies Show Similarity Between Lusduna and Lantus

Data from 2 studies, accepted for publication in Diabetes, Obesity and Metabolism, show that Merck’s follow-on insulin glargine has pharmacokinetic (PK) and pharmacodynamic (PD) similarity to Sanofi’s originator insulin glargine, Lantus. The euglycemic clamp studies—1 in patients with type 1 diabetes and 1 in healthy volunteers—were conducted to demonstrate PK and PD similarity between Merck’s MK-1293 and both European Union (EU)- and US-sourced Lantus. Both studies met their primary PK and PD endpoints, and the follow-on product was well tolerated.

MK-1293, which Merck plans to market as Lusduna, gained tentative approval from the FDA in July. However, the agency will not issue its final approval until a patent infringement suit, brought by Lantus’ maker, Sanofi, concludes.

Sanofi has already seen sales of its insulins erode by 23.9% due to competition from European biosimilars and US follow-on insulins such as Basaglar (made by Boehringer Ingelheim). The fact that the drug maker has also seen its originator insulin glargine excluded from CVS and United Health’s formularies suggests that Sanofi is incented to delay Lusduna’s entry into the US market.

Insulin Price Competition Gains Momentum

While Merck waits to launch its insulin glargine, Danish drug maker Novo Nordisk announced that it is currently negotiating its basal insulin prices with pharmacy benefit managers (PBMs) and managed care organizations in the United States. The company’s prices for insulin products could drop below 2017 levels due to what CEO Lars Fruergaard Jørgensen called “a tough competitive environment.”

However, tough competition may not mean increased market share for biosimilar products. Steven B. Miller, MD, senior vice president and chief medical officer of the PBM Express Scripts, has said that he expects innovator product manufacturers to “do everything they can to prevent loss of market share…I think they’re going to make it extremely hard for biosimilars to penetrate the market.” Despite his prediction that reference drug makers will continue to do all that they can to protect their sales, Miller noted that 5 companies are currently developing follow-ons to Lantus, with $5.6 billion potentially at stake.

Meanwhile, drug makers are looking to innovative products as a way to maintain their earnings in the endocrinology market. A report by the Analysis Group identified 749 projects and 432 products—all targeting diabetes and related complications—currently under development for the US market.

When Will Patients See Relief from High Prices?

As companies vie for insulin market share, some providers worry that patients’ concerns about pricing are being ignored. Robert Gabbay, MD, PhD, FACP, said, “From the patient level, it’s, in some ways, a travesty, really. People with type 1 diabetes depend on insulin to stay alive, and the cost of insulin has skyrocketed over the last decade…Unfortunately, this is one of those situations where the patient loses in the end.”

State governments have been crafting legislation to ensure that the patient doesn’t lose for much longer; the National Academy for State Health Policy has identified a number of successful drug pricing bills that have been passed or enacted at the state level, including a new Nevada law that requires drug manufactures and PBMs to disclose information concerning diabetes-drug pricing to the state.

Meanwhile, patients are signaling readiness to accept biosimilars and follow-ons in order to save on out-of-pocket costs; a CVS Health survey of 2000 people in the United States found that 60% of patients would accept a biosimilar in place of a branded biologic if it would provide them with a cost-savings.