FDA Approves Soliris Biosimilar Epysqli by Samsung Bioepis for Rare Blood Disorders

The US Food and Drug Administration (FDA) has given the green light to Samsung Bioepis for their biosimilar drug Epysqli (eculizumab-aagh), designed as an alternative to AstraZeneca’s Soliris. This approval marks a significant advance in the treatment of two rare hemolytic diseases: paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uraemic syndrome (aHUS).

Epysqli, a complement inhibitor, is now officially recognised for its effectiveness in reducing haemolysis in PNH patients and for preventing complement-mediated thrombotic microangiopathy in those suffering from aHUS. According to statistics, these conditions affect approximately 50,000 and 5,000 individuals in the United States, respectively.

Typically, eculizumab is a cornerstone treatment for both PNH and aHUS. Despite its efficacy, there are issues related to its accessibility and long-term use. Around 70% of PNH patients receiving eculizumab do not adhere to the prescribed dosage, and nearly two-thirds discontinue treatment within an average span of 1.5 years. One of the main reasons cited for this discontinuation is the high cost of treatment.

The concept of biosimilars, as defined by the FDA, refers to biological products that are highly similar to an already approved reference product, with no significant clinical differences in terms of safety and effectiveness. This similarity offers patients an alternative that maintains the same therapeutic benefits as the original drug but potentially reduces healthcare costs.

The FDA’s endorsement of Epysqli is based on comprehensive evidence demonstrating that it is "highly similar" to Soliris, without any substantial differences in safety, purity, or potency. This approval makes Epysqli the eighth biosimilar from Samsung Bioepis to be approved in the U.S. market.

Christopher Hansung Ko, President and CEO of Samsung Bioepis, expressed optimism about the approval. He highlighted that this milestone holds great promise for patients with PNH and aHUS, emphasizing that biosimilars can significantly lower healthcare costs and enhance access to essential treatments.

This development follows closely on the heels of another significant approval for Samsung Bioepis. Just three weeks prior, the FDA approved Pyzchiva (ustekinumab-ttwe), another biosimilar from Samsung, which references Johnson & Johnson’s Stelara. Pyzchiva, which will be marketed in the U.S. by Sandoz, is approved for treating a variety of conditions, including moderate-to-severe plaque psoriasis, active psoriatic arthritis, moderately-to-severely active Crohn’s disease, and moderately-to-severely active ulcerative colitis. It also extends to pediatric patients with moderate-to-severe plaque psoriasis and active psoriatic arthritis.

Samsung Bioepis and Sandoz entered into a commercialisation agreement for Pyzchiva last year. This agreement covers multiple regions including the U.S., UK, European Economic Area, Switzerland, and Canada.

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