- The Food and Drug Administration has approved Viatris and Biocon's long-acting insulin Semglee, making it the first so-called interchangeable biosimilar product to reach the market in the U.S.
- The "interchangeable" tag ensures the drug can be directly substituted by pharmacists for Sanofi's Lantus. While the FDA has approved 29 other biosimilars, none have been awarded the coveted designation, which allows pharmacists to directly swap in a copycat version of a branded biologic. Semglee also has 12 months of exclusivity before the FDA can approve another interchangeable competitor.
- The decision places more pressure on insulin manufacturers, which have come under heavy criticism for high prices that have pushed their drugs out of reach for some patients. In 2016, Eli Lilly launched a Lantus competitor called Basaglar, that prompted some insurers to stop covering the Sanofi product, but it didn't win the interchangeable designation Semglee now has.
The promise of biosimilars — that competition would bring down the prices of complex biological drugs — hasn't materialized in the U.S. in the way many expected. Complex patent webs have kept some approved biosimilars off the market for years, as has been the case for potential lower-cost rivals to AbbVie's Humira and Amgen's Enbrel. Contracting and pricing strategies for branded drugs have also prevented some other biosimilars from making a bigger dent in the market.
Unlike with generic drugs, pharmacists haven't been authorized to directly substitute earlier biosimilars when they receive a prescription. Physicians, then, are left to request a biosimilar when writing the prescription. Or insurers must dictate that they will only pay for a biosimilar version.
That should finally change with Semglee. Viatris and Biocon's drug will be the sixth long-acting insulin on the market, offering an alternative not just to Lantus but also to Novo Nordisk insulins like Tresiba and Levemir, although it is not directly substitutable to those two agents. Biosimilars have, on average, launched with initial prices roughly 15% to 35% lower than their branded counterparts, according to an FDA statement.
"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," acting commissioner Janet Woodcock said in the statement.
In order to qualify Semglee as interchangeable, Viatris and Biocon had to demonstrate that there are no differences between the biosimilar and Lantus on safety, purity and potency. The two also had to prove the clinical benefits would be the same and that there would no risks of harm or diminished efficacy if patients switch from Lantus to Semglee.
Long-acting insulins typically are dosed once or twice daily to keep patients' blood sugar under constant control, but take hours to take effect. For some patients, that is enough to keep from experiencing dangerous elevations in blood sugar, but others need to supplement with shorter-acting insulins at mealtimes to maintain control.
Viatris plans to begin a commercial launch by the end of the year and transition its current Semglee manufacturing lines to the interchangeable product.