The pharma company Ipsen has lost the latest round of its legal effort to have its blockbuster cancer product Somatuline Depot classified as a biologic, instead of a drug.
Ipsen had sued after the FDA classified Somatuline Depot as a drug, which comes with a shorter period of sales exclusivity than biologic products. The FDA won in district court in 2023, and the US Court of Appeals in DC released its ruling on the company’s appeal, saying the FDA was correct.
The appellate court found that Ipsen’s attempt to merge the FDA’s definition of a “drug product” from a regulation interpreting a different law “to trump the definition of a ‘biological product’ specified by Congress in the relevant statute just does not work.”
“The FDA considered whether the lanreotide nanotube assembly has structural and functional characteristics that are ‘generally associated with proteins.’ It ultimately concluded that the lanreotide nanotube assembly fails on both fronts,” the court said in the opinion.
The court said it largely deferred to the FDA’s expertise, noting that the agency’s decision “to analyze just lanreotide acetate (which is responsible for Somatuline Depot’s therapeutic effect) and not the nanotubes (which are not) was unambiguously correct. But even if the FDA’s regulations were ambiguous on this point, the Court would defer to the FDA’s interpretation as reasonable.”
Courts relying on the FDA’s expertise in some matters could become more of a rarity soon, following the Supreme Court’s decision in June to overturn a longstanding legal doctrine, known as Chevron deference, that has effectively ensured courts relied on federal agencies for their subject matter knowledge.
Somatuline, which is used to treat acromegaly and to slow the growth of gastrointestinal and pancreatic neuroendocrine tumors, pulled in €522 million ($567 million) in the first half of 2024, which is about €6 million ($6.5 million) less than the first half of 2023, the company said on Thursday.
While generics of somatuline have been introduced across Europe and the US, Ipsen said it’s seeing “limited sales erosion, benefiting from generic-lanreotide shortages in several countries in Europe in the first half of the year, and a solid performance in Rest of World.” In North America, sales declined by 6.3%, the company said, “primarily reflecting adverse U.S. pricing.”
Ipsen did not respond to a request for comment on the appeals court’s decision.