Samsung Bioepis said Monday that the FDA approved its biosimilar to AstraZeneca’s blockbuster immunosuppressive drug Soliris. But the approval, for two types of rare blood disorders, didn’t come with the same interchangeability designation that Amgen won for its own biosimilar earlier this year.
The FDA has pushed in recent months to make it easier to obtain interchangeability designation. In May, the agency approved Amgen’s monoclonal antibody Bkemv as the first interchangeable biosimilar to Soliris, which last year saw $3.7 billion in sales.
A spokesperson declined to comment on when Samsung’s drug, Epysqli, might launch, though Amgen has said it cannot launch Bkemv until March 1, 2025. Neither Samsung nor Amgen has revealed where they’ll price their drugs. Last October, Samsung launched Epysqli in Germany, Italy, and Spain.
The FDA’s approval of Epysqli, according to Samsung, is based on analytical, nonclinical and clinical data demonstrating Epysqli is highly similar to Soliris, with no clinically meaningful differences in safety, purity and potency.
The company said it ran a Phase 1 safety study and a Phase 3 in paroxysmal nocturnal hemoglobinuria patients and found clinical equivalence in efficacy, safety, and immunogenicity between the biosimilar and Soliris.