FDA denies Ipsen's citizen petition for blockbuster drug Somatuline
24 May 2024
Drug ApprovalBiosimilar
US drug regulators have turned down Ipsen’s effort to slow down generic competition for its blockbuster drug Somatuline Depot, which is used to slow the growth of some tumors as well as for the rare disease acromegaly.
The FDA denied the company’s 2019 citizen petition, in which Ipsen asked the agency to set up several requirements for companies that wanted to get generic versions of the drug approved. Somatuline was first approved in 2007, and brought in $1.1 billion in 2023 — 34% of the company’s sales, according to its
financial filings
. Revenue from the drug has been declining as generics have come on the market in recent years.
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