The US Food and Drug Administration (FDA) has approved Samsung Bioepis’ Epysqli (eculizumab-aagh), a biosimilar to AstraZeneca’s Soliris, for two rare diseases characterised by the breakdown of red blood cells.
The complement inhibitor is now authorised to reduce haemolysis in patients with paroxysmal nocturnal haemoglobinuria (PNH) and to inhibit complement-mediated thrombotic microangiopathy in those with atypical haemolytic uraemic syndrome (aHUS).
Eculizumab is a standard treatment for PNH and aHUS, which affect approximately 50,000 and 5,000 people in the US, respectively. However, about 70% of eculizumab-treated PNH patients are not dosed according to the label and two-thirds discontinue the drug within an average of 1.5 years, which Samsung said may be partly caused by high treatment costs.
Biosimilars, according to the FDA, are biological products that are highly similar to and have no clinically meaningful differences from an existing FDA-approved product. This means patients can expect the same safety and effectiveness from the biosimilar as they would from the reference product, but may potentially benefit from lower healthcare costs.
The regulator’s decision on Epysqli, which is now the biopharma’s eighth biosimilar approved in the US, was supported by a totality of evidence demonstrating that the drug is “highly similar” to Soliris and has no clinically meaningful differences to the reference medicine in terms of safety, purity and potency, Samsung outlined.
Christopher Hansung Ko, president and chief executive officer at Samsung Bioepis, said the approval “marks an important milestone for PNH and aHUS communities” since biosimilars “have a potential to positively impact patients and healthcare systems by reducing healthcare costs and improving access to treatments”.
The authorisation comes just three weeks after the FDA approved Samsung’s Pyzchiva (ustekinumab-ttwe), a biosimilar referencing Johnson & Johnson’s Stelara.
Pychiva, which will be commercialised in the US by Sandoz, can now be used to treat adults with moderate-to-severe plaque psoriasis, active psoriatic arthritis, moderately-to-severely active Crohn’s disease and moderately-to-severely active ulcerative colitis, as well as paediatric patients with moderate-to-severe plaque psoriasis and active psoriatic arthritis.
Samsung Bioepis and Sandoz entered into a commercialisation agreement for Pyzchiva last year for the US, UK, European Economic Area, Switzerland and Canada.
