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In a long-awaited move, the Food and Drug Administration has approved the first so-called interchangeable biosimilar version of insulin, which the agency suggested may reduce the price of a life-saving treatment that has been a poster child for the high cost of medicines.

The agency endorsed Semglee, a copy of long-acting Lantus (insulin glargine), that it first approved last year. Now, though, the copycat version has also been designated as interchangeable, a regulatory term that means Semglee can be substituted at the pharmacy for Lantus in the same way that generic drugs are substituted for equivalent brand-name medicines.


In general, biosimilar medicines are variants of brand-name biologics. They are are supposed to cost less but yield similar health outcomes. With this added step, though, FDA officials are touting their decision as a meaningful move toward combatting the high cost of insulin, which has been a flashpoint in the national debate over affordable access to prescription drugs.

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