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FDA Lets Pharmacies Substitute Branded Insulin With Knockoff Product, in First for a Biologic Drug

For the first time, U.S. regulators have said that a knockoff version of a biologic drug is interchangeable with its branded equivalent, a milestone in the yearslong effort to bring greater competition to the market for expensive biologic drugs.


The U.S. Food and Drug Administration on Wednesday said the biosimilar insulin product Semglee is interchangeable with Sanofi SA’s Lantus, a designation that allows pharmacists to automatically substitute Semglee for prescriptions for Lantus, one of the top-selling insulins in the world.


Semglee is made by Viatris Inc. VTRS +1.03% and Biocon Biologics Ltd. and was first approved by the FDA last year. But doctors would have to specifically prescribe the biosimilar version, rather than allowing pharmacists to substitute it for Lantus when filling the prescription. The companies said they would launch the product with new labeling on interchangeability before the end of the year.


A Viatris spokeswoman declined to disclose how much the company will charge for the interchangeable Semglee product.


The current list price for a pack of five Lantus injection pens is $425.31, a Sanofi spokeswoman said. When Semglee was originally introduced last year, the companies charged $147.98 per five-pen package.


A majority of patients pay $0 or $10 per prescription for Sanofi insulins through the company’s copay assistance program, the spokeswoman said. For uninsured patients, the company has a program that allows patients to pay a fixed price of $99 a month.


Insulin, a lifesaving medication used to control blood sugar levels in people with diabetes, became a flashpoint in recent years in the debate over rising drug prices. The cost of insulin led some patients, particularly those without health insurance or coverage requiring significant out-of-pocket payments, to ration or skip doses of the medication.


In 2010, Congress created a mechanism for drugmakers to develop biosimilar copies of so-called biologic drugs—made from living cells—that had lost patent protection. The aim was to create more competition and bring down prices in the same way that generics had for traditional pharmaceuticals made from chemicals.


But the biosimilar market hasn’t delivered as much cost-savings as policy analysts had hoped, partly because there haven’t been any approved biosimilars designated as interchangeable by the FDA.


“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 healthcare costs,” acting FDA Commissioner Janet Woodcock said in a statement.

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