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.
The 2019 petition proposed making any companies applying for a generic to meet five conditions, including an in vivo study showing the generic version releases the therapeutic chemical just like the brand version, and that the drug’s delivery device would be as “functional and useable” as Ipsen’s, among other requirements.
In its 17-page response, the FDA pushed back against each of the company’s requirements, saying that it disagreed that in vitro testing was insufficient, and that the agency “has wide discretion to determine the type of evidence required to demonstrate [bioequivalence].”
Ipsen did not respond to a request for comment by press time.
The company had another run-in with the FDA last year over Somatuline, when a DC district court sided with the agency in a lawsuit brought by Ipsen. Ipsen argued that the FDA was wrong when it decided to regulate Somatuline as a drug instead of a biologic.