FDA Approves Samsung's Soliris Biosimilar Epysqli

The FDA has given the green light to Samsung Bioepis' Epysqli (eculizumab-aagh) as a biosimilar to AstraZeneca's Soliris (eculizumab). This approval focuses on the treatment of paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uremic syndrome (aHUS). This decision comes shortly after Amgen's Bkemv (eculizumab-aeeb) received FDA approval in May as the first interchangeable biosimilar to Soliris.

Samsung's biosimilar, Epysqli, is specifically designed to reduce haemolysis in PNH patients and to prevent complement-mediated thrombotic microangiopathy in individuals with aHUS. It is not intended for use in patients with Shiga toxin E. coli-related HUS. The approval from the FDA was based on a comprehensive review of multiple types of data, collectively referred to as the "totality of evidence". This includes analytical tests, non-clinical studies, and clinical trial results that collectively demonstrate that Epysqli is highly similar to Soliris in terms of safety, purity, and potency.

The data package submitted to the FDA included a pivotal Phase III clinical trial involving patients with PNH, which showed that Epysqli is clinically equivalent to Soliris. This rigorous evaluation affirmed that there are no significant differences between the two drugs in terms of safety and efficacy.

Epysqli, which was previously known by the designation SB12, has already been approved by regulatory bodies in the European Union and South Korea for the treatment of these rare blood disorders. The FDA's recent approval marks the eighth biosimilar that Samsung Bioepis has successfully brought to the U.S. market.

This latest development further solidifies Samsung Bioepis’ position in the global biosimilars market, showcasing its capability to produce high-quality, cost-effective treatment options. The approval also highlights the FDA's growing acceptance and endorsement of biosimilars as viable alternatives to original biologic drugs, potentially leading to increased competition and reduced healthcare costs.

In summary, the FDA's approval of Epysqli as a biosimilar to Soliris represents a significant milestone for Samsung Bioepis. It underscores the company's ongoing commitment to delivering innovative therapies for rare blood diseases and enhances treatment options available to patients with PNH and aHUS.