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French biopharma Ipsen has lost a court case against U.S. regulators to have its blockbuster cancer medication Somatuline Depot regarded as a ‘biologic’ instead of a ‘drug.’
The drugmaker had sued the U.S. Food and Drug Administration (FDA), after which the regulators won in the District Court for the District of Columbia last year. Now, the appeals court has also sided with the FDA and this decision could have broader implications for the industry.
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Ipsen vs. FDA: the court case
It all began when the FDA decided to change the definition of the term ‘biologic’ in 2020, a term whose meaning has been modified over time. Previously, proteins that are chemically synthesized were ruled out under the definition. The 2020 amendment describes a biologic as a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein, or analogous product that could cure or treat a human disease. According to the FDA, a protein is “any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size.”
As a result, the FDA was required to transition therapies that were previously categorized as a drug but now meet the new definition of a biologic, to be regarded as a biologic. It released a list of biological products that were previously marketed as drugs, based on this ruling. Ipsen’s Somatuline Depot was not on the list despite the biotech’s claims that its therapy fit the revised definition.
As biologics and drugs undergo different regulatory approval processes, Somatuline Depot, which was approved a decade ago for gastroenteropancreatic neuroendocrine tumors (GEP-NETs) – a rare tumor originating in the gastrointestinal tract – and in 2007 for acromegaly – the overproduction of the growth hormone – was greenlit under the New Drug Application (NDA).
Is Somatuline Depot a protein?
Somatuline Depot is an injectable that contains the active ingredient lanreotide acetate, a somatostatin analog that inhibits insulin-like growth factor-1 (IGF-1). It mimics the hormone somatostatin and is eight amino acids long. While its active ingredient doesn’t meet the FDA’s definition of a protein containing 40 amino acids, Ipsen argued that the drug in its finished form that is linked together into nanotubes exceeds 40 amino acids.
The pharmaceutical challenged the FDA’s failure to recognize its treatment as a biologic and only consider the size of the active ingredient alone instead of the finished drug product.
Meanwhile, New York-based InvaGen Pharmaceuticals’ lanreotide acetate generic was cleared by the FDA in late 2021 under the Abbreviated New Drug Application (ANDA), which allows generics to seek approval. The stakes are high for Ipsen, which could face competition sooner if the compound is classified as a drug instead of a biologic.
Biologics vs drugs: how different are they?
Unlike drugs, biologics enjoy a longer period of sales exclusivity in the market. Moreover, generics of biologics must file an Abbreviated Biological License Application (ABLA) instead of an ANDA. The FDA nod for ABLA is based on the biosimilarity or interchangeability of the generic when compared to a biologic. A biosimilar is a therapeutic product that is ‘highly similar’ to another product, in this case, the biologic Somatuline Depot. An interchangeable is a biosimilar that reaps the same clinical results as the original therapy.
As InvaGen’s drug was approved under the Drug Act and not the Biologics Act, it was able to use Ipsen’s clinical data for Somatuline Depot when filing its regulatory application. Ipsen contends that had the FDA switched Somatuline Depot’s status to that of a biologic, InvaGen would not have been able to use its clinical data for its approval – and Ipsen could have continued to benefit from being the only player in the market. The biopharma faced market share losses owing to competition from generics.
However, the appeals court granted the win to the defendants FDA and InvaGen. Since an active ingredient is defined as “any component that is intended to furnish pharmacological activity,” the court agreed with the drug regulator that the lanreotide nanotube assembly of Ipsen’s analogous drug “does not have a specific biological function that is linked to its structure,” and that lanreotide acetate is not a protein, and therefore, not a biologic.
This is a rare victory for the FDA since the U.S. Supreme Court recently struck down the longstanding Chevron Deference that guided courts to defer to agencies – like the FDA – when making their judgment. Legal experts have warned that this overturn could see an uptick in challenges to regulatory decisions.
It could impact how long FDA approvals take and could even make the FDA “more focused on defending its decisions rather than being adaptive,” according to a report by Fitch Ratings.
Ipsen declined to comment on the ruling.
