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.
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.
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
Alvotech’s Stelara Biosimilar, Selarsdi, Receives FDA Approval
April 16th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
BioRationality: Removing the Misconceptions Surrounding Interchangeability
April 15th 2024Sarfaraz K. Niazi, PhD, outlines the current state of interchangeable biosimilars in the US and policy changes needed to clear up misconceptions surrounding the meaning behind interchangeability designations.
What Clinicians Need to Know About Using Biosimilars to Treat IBD
April 13th 2024A review article, intended to act as a guide for clinicians, summarizes the available infliximab and adalimumab biosimilars for treating inflammatory bowel disease (IBD) as well as others that are coming down the pipeline.