FDA approves Samsung Bioepis’ EPYSQLI as Soliris biosimilar

2024-07-23
Pharmaceutical Technology
上市批准临床1期临床结果临床3期细胞疗法
The asset is indicated to treat paroxysmal nocturnal haemoglobinuria. Credit: MMC-Rodenbusch / Shutterstock.
Samsung Bioepis has announced thparoxysmal nocturnal haemoglobinuriab-aagh) biologics licence application (BLA) by the US Food and Drug Administration (FDA) as a biosimilar to Soliris (eculizumab).
Samsung Bioepisvers the treatment of paroxysmal noEPYSQLI heculizumab-aagh(PNH) for reducing haemolysis and atypical haemoFood and Drug Administration (FDA)vert complement-mediated thrombotic microangiopathy.
EPYSQLIregulator’s approval for EPYSQLI is supportecoli-related haemolytic uraemic syndrome (STEC-HUS)non-clinical and clinical data, confirming its high similarity to Soliris without any significant differences in safety, purity and potency.
A randomised, double-blind, threEPYSQLIparallel-group, single-dose Phase I trial enrolling healthy subjects demonstrated pharmacokinetics (PK) equivalence and comparablSolirisacodynamic, safety, tolerability and immunogenicity profiles between EPYSQLI and Soliris.
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A randomised, double-blind, multicentre, cross-over Phase III trial in PNH patients showed clinical equivalence of EPYSQLI and Soliris in terms of efficacy, safety, PK and immunogenicity.
Astellasab, tOsaka Universityent in Soliris, is a monoclonal antibody and anti-C5 complement inhibitor.
Biosimilars such as EPYSQLI are biologic medicines that are highly similar to an existing FDA-approved biologic with no clinically meaningful differences.
They are expected to reduce the financial burden on the healthcare systPNHand improve patient access to biologic thEPYSQLI, as Solirisst meet the same standards for quality, safety and efficacy as the reference products.
Eculizumab US, EPYSQLI also receivedSolirisal from the European Commissionanti-C5 complement inhibitorC5 complementtry of Food and Drug Safety as a Soliris biosimilar to treat PNH and aHUS.
Samsung Bioepis presEPYSQLInd CEO Christopher Hansung Ko said: “The FDA approval of EPYSQLI as a biosimilar to Soliris marks an important milestone for the PNH and aHUS communities since biosimilars have the potential to positively impact patients and healthcare systems by reducing healthcare costs and improving access to treatments.
“Our mission has been, and always will be improving the lives of patients by providing quality-assured, safe and effective biologic medicines, and our work to fulfil this mission is expanding into rare disease areas where patients continue to suffer from limited access to life-enhancing medicines.”
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