First Interchangeable Biosimilar Insulin Gets FDA Approval

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First Interchangeable Biosimilar Insulin Gets FDA Approval

The U.S. Food and Drug Administration (FDA) has approved the biosimilar insulin Semglee (insulin glargine-yfgn) as a product that is interchangeable with Lantus (insulin glargine), according to a new announcement from the federal agency.

A biosimilar is like a generic drug, except the term applies to biologic drugs — those that are derived from cells or tissues, or created using biotechnology. Unlike traditional drugs with a fairly simple chemical structure, biologic drugs tend to consist of large, complex molecules or combinations of molecules that can’t be easily defined. For this reason, pharmaceutical companies can’t create generic versions of biologic drugs, which are defined by having the same active ingredient as a brand-name equivalent that is already FDA-approved. Instead, a company that creates a biosimilar drug must show that it is “highly similar to” and has “no clinically meaningful differences from” an approved reference product. This is typically demonstrated through a clinical trial of the biosimilar, to see how well it treats at least one of the approved indications of the reference drug.

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All varieties of insulin are biologic drugs, and until recently, each type of insulin was available from only one manufacturer. This means that even if the manufacturer sold a discounted version of its product, it didn’t face any competition from an outside product that could be easily substituted. While Semglee was approved as a biosimilar insulin in June 2020, as noted in a Medscape article, only now is it officially designated as interchangeable with Lantus — meaning that people who already use Lantus, a long-acting insulin, can use Semglee in exactly the same way, and even switch back and forth between the two. Similarly, under rules in place in many states, pharmacists can substitute Semglee for Lantus if doing so leads to cost savings for the pharmacy or the patient.

“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,” said acting FDA commissioner Janet Woodcock, MD, in the announcement. She underscored the FDA’s commitment to “safe, effective and high-quality medications at potentially lower cost.”

According to the FDA, biosimilars typically launch in the United States with list prices that are 15% to 35% lower than those of the reference drug that they’re based on. But that doesn’t mean a given biosimilar will be less expensive for everyone or even for most people who use it, once insurance coverage and contracts involving pharmacies are factored in. One reason that biosimilars aren’t even less expensive compared to reference products is that nearly all biologic drugs involve complex, rigorous manufacturing and distribution processes to ensure quality control and potency. Still, it’s likely that having at least some competition will lead to lower prices, over time, than if no competition existed.

Semglee is available in vials containing 10 milliliters (ml) and in prefilled insulin pens containing 3 ml, and it is typically injected once daily. It is manufactured by Mylan Pharmaceuticals, Inc.

Want to learn more about insulin? Read “What Does Insulin Do?”  “Insulin: What You Need to Know” and “Insulin Basics.”

Quinn Phillips

Quinn Phillips

Quinn Phillips on social media

A freelance health writer and editor based in Wisconsin, Phillips has a degree from Harvard University. He is a former Editorial Assistant for Diabetes Self-Management and has years of experience covering diabetes and related health conditions. Phillips writes on a variety of topics, but is especially interested in the intersection of health and public policy.

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