July 30, 2021 – The FDA on Wednesday ruled that Viatris Inc.’s Semglee was interchangeable with widely used Lantus, a long-acting insulin.
This is 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.
Approval of a second such interchangeable biosimilar of a fast-acting insulin appears imminent from the same developers, Viatris (Pittsburgh, PA) and its partner, Biocon (India).
Mylan N.V., one of two companies that merged to create Viatris last December, launched Semglee in the U.S. last summer.
Health data firm IQVIA projects U.S. savings from increasing use of biosimilars from 2020 through 2024 will top $100 billion.