Basaglar, a biosimilar to Lantus, is expected to face patent expiration in the United States in 2027 [1]. Specifically, the main patent protecting Lantus, U.S. Patent No. 6,565,814, is set to expire in 2027 [2]. This patent covers the insulin glargine product [2].
When does Basaglar's market exclusivity end?
Basaglar's market exclusivity is tied to the patent expiration of its reference product, Lantus [1][2]. The primary patent for Lantus is scheduled to expire in 2027 in the U.S. [2].
What happens after Basaglar's patent expires?
Following patent expiration, the market for Basaglar, and biosimilars in general, typically opens up to increased competition. This can lead to lower prices for patients and more treatment options [1]. Other companies may seek to develop and market their own biosimilars of insulin glargine [1].
Who manufactures Basaglar?
Basaglar is manufactured by Eli Lilly and Company [3]. It is a biosimilar to Sanofi's Lantus [3].
How does Basaglar compare to Lantus?
Basaglar is a biosimilar to Lantus, meaning it is a biological product that is highly similar to an already approved biological product (the reference product) and has no clinically meaningful differences in terms of safety, purity, and potency [1]. It is approved for the same conditions as Lantus, including type 1 and type 2 diabetes [3].
What are the implications of patent expiration for insulin prices?
Patent expiration for insulins like Lantus can have significant implications for pricing. Historically, insulins have faced challenges with affordability [1]. Increased competition from biosimilars after patent expiry has the potential to drive down costs, making these essential medications more accessible [1].
Are there other biosimilars for insulin glargine?
Yes, the market for insulin glargine biosimilars is developing. Several companies have been developing or have launched biosimilars to Lantus [1].
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Sources:
1. https://drugpatentwatch.com/
2. "U.S. Patent 6,565,814"
3. Eli Lilly and Company