Lilly wins FDA approval for second interchangeable insulin biosimilar

2022-11-17

上市批准

The emergence of interchangeable biosimilars since the pathway opened up has been slow. But the FDA on Thursday approved the fourth interchangeable biosimilar, which is also the second interchangeable biosimilar insulin product. Eli Lilly’s Rezvoglar (insulin glargine-aglr), which converted to an interchangeable after an earlier biosimilar approval in December 2021, follows Viatris’ Semglee in seeking out a niche to compete with Sanofi’s blockbuster Lantus (insulin glargine). And while the FDA and biosimilar experts have said that interchangeables will drive price competition, Viatris had launched both a high- and lower-priced version of Semglee to deal with the market dynamics, and Lilly did not respond to a request for comment on the price of Rezvoglar moving forward. These interchangeable designations mean Semglee and Rezvoglar may be substituted at the pharmacy level for Lantus, without a doctor’s prescription, and as long as the state pharmacy law permits the switch. The FDA has also been more permissive of approving interchangeable biosimilars, which come with 12 months of exclusivity, without meeting all of the stipulations that the agency initially laid out. For instance, Semglee won approval as an interchangeable even though FDA said a clinical immunogenicity study comparing Semglee to Lantus was not necessary. Similarly, biosimilar company Coherus BioSciences won approval in August for Cimerli (ranibizumab-eqrn), an interchangeable biosimilar to Roche’s injection Lucentis, without running a switching study to see how patients fared after moving from Lucentis to the interchangeable. The agency said in this case it: The future for interchangeable biosimilars will likely hit more insulins and AbbVie’s blockbuster Humira next year. In the case of Humira, Boehringer Ingelheim is ready to launch its adalimumab interchangeable, and several others may be forthcoming next year. Over the next five years, the FDA’s biosimilar leaders are pushing forward with a sharper focus on interchangeables too. “What we’re going to really focus on in BsUFA III is how to develop an interchangeable product,” Jacqueline Corrigan-Curay, who’s also leading the search for a new director of FDA’s Office of Generic Drugs, explained at a recent industry conference.

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