The FDA has approved Langlara, an interchangeable biosimilar to Lantus.
The interchangeability designation allows pharmacists to substitute Langlara for Lantus without prescriber intervention in states that permit it, according to a May 5 news release from Lannett, which owns Langlara manufacturer Sunshine Lake Pharma.
The insulin glargine product is approved for adults and pediatric patients with Type 1 diabetes and adults with Type 2 diabetes. Interchangeable biosimilars meet additional FDA requirements demonstrating they are expected to produce the same clinical result as the reference product and can be substituted without increased safety or efficacy risks, even when patients switch between products, the release said.
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