USA — TheU.S Food and Drug Administration (FDA) has designated Eli Lilly’s Rezvoglar as “interchangeable” with Sanofi’s Lantus, making it the second insulin biosimilar to receive the prestigious designation.
Rezvoglar is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.
The approval comes nearly a year and a half after Viatris and Biocon’s Semglee became the first insulin biosimilar to be granted interchangeable status, securing 12 months of exclusivity before the FDA could apply the label to another competitor.
Currently, Viatris, the drug developer, markets 2 versions of Semglee: an unlabeled version and a labeled interchangeable version.
Biosimilar interchangeability has been touted for its potential to improve drug access to high-cost biologics by offering alternatives at competitive prices.
Rezvoglar, which the Food and Drug Administration previously approved in December 2021, can now be swapped out as a substitute for Sanofi’s Lantus at the pharmacy counter without prior authorization from a certified medical prescriber.
Rezvoglar is available in 3 mL prefilled pens and is administered subcutaneously once daily. It may cause serious side effects, including hypoglycemia, severe allergic reactions, hypokalemia and heart failure.
There are several long-acting insulins on the market, and the addition of Semglee and Rezvoglar gives patients and providers even more options.
The increased competition may act as another lever for insurers to control insulin costs in the United States, which have long been criticized by lawmakers and the public.
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.
Next year, interchangeable biosimilars are expected to hit more insulins and AbbVie’s blockbuster Humira.
In the case of Humira, Boehringer Ingelheim is preparing to launch its adalimumab interchangeable, and several others are expected to follow suit early next year.
Over the next five years, the FDA’s biosimilar leaders will place a greater emphasis on interchangeables.
In a separate development, the FDA has approved Provention Bio’s Tzield injection to delay the onset of stage 3 type 1 diabetes.
Tzield is indicated for adults and pediatric patients 8 years and older who currently have stage 2 type 1 diabetes.
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