FDA approves use of biosimilar insulin as automatic substitute for costly brand-name
U.S. regulators took action Wednesday that should make it easier to get a cheaper near-copy of a brand-name insulin at the drugstore.
Doctors must now prescribe what's called a biosimilar drug, or OK its use as a substitution for a more expensive brand-name insulin.
The Food and Drug Administration has given its approval to Semglee, the first biosimilar cleared as a substitute for Lantus, a widely used fast-acting insulin.
Biosimilar drugs are not the same as generic drugs. Unlike generic drugs, which share the same chemical composition as their pricier brand-name counterparts, biosimilar drugs are "highly similar" duplications. The FDA agreed that Viatris Inc.'s Semglee was interchangeable with Lantus.
OK to automatically swap
Wednesday's move will allow pharmacists to automatically substitute the cheaper version when filling prescriptions, just as they do with generic pills for other kinds of drugs.
It's the FDA's first approval of an "interchangeable" biosimilar, a near-copy of an injected biologic medicine that's manufactured inside living cells. It could save diabetics and health plans millions of dollars annually and encourage other drugmakers to create more biosimilar medicines. Health data firm IQVIA projects U.S. savings from increasing use of biosimilars from 2020 through 2024 will top $100 billion.
"This is a momentous day for people who rely daily on insulin for treatment of diabetes, as biosimilar and interchangeable biosimilar products have the potential to greatly reduce health care costs," Dr. Janet Woodcock, the FDA's acting commissioner, said in a statement.
Depending on the pharmacy, Semglee injector pens cost about $150 to $190 without insurance for a typical month's supply, compared to $340 to $520 for the same supply of Lantus.
Insulin prices have escalated for years, making the drug unaffordable for some people with diabetes. The rising cost has drawn criticism from lawmakers and patients alike, with some diabetics saying they've had to ration insulin or make other risky decisions because of problems affording it.
Walmart on Tuesday said it would start selling its own private brand of analog insulin with prices that are up to 75% below the cost of competing products.
Although insulin has been used as medication for roughly a century, no generic versions of the drug are available. Only three manufacturers — Eli Lilly, Novo Nordisk and Sanofi — control 99% of the market. Walmart said that its private brand insulin will be made by Novo Nordisk.
Aimee Pichee contributed to this report.