A formidable competitor to Soliris, 'Episcli', makes its market entry in earnest.

Starting from the Apr. 1st, Episcli, a biosimilar of Soliris (eculizumab), one of the highest-cost pharmaceuticals, has entered the market in earnest.

Episcli, a biosimilar of Soliris, which costs between 300 to 400 million KRW annually, is the first biosimilar introduced by Samsung Bioepis in the field of rare and intractable diseases in Korea.

The price is set at around 2.51 million KRW (2,510 USD), which is 30% cheaper per vial compared to Soliris, which costs 3.6 million KR (2,667 USD) per vial. When considering the annual cost, Soliris is expected to be in the 250 million KRW (185,253 USD)range, while Episcli will be in the 140 million KRW (103,742 USD)range.

Among the three indications that Soliris holds, Episcli has secured indications for paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). Soliris, on the other hand, has its reimbursement for one of the three indications, neuromyelitis optica spectrum disorder (NMOSD), applied from the 1st of this month.

Until now, the main target area for Soliris has been in the field of aHUS, and with the entry of Episcli, competition is expected to intensify. However, breaking through the high brand loyalty barrier of original diseases remains a challenge.

Samsung Bioepis plans to operate patient support programs to secure entry into the domestic market, although clear plans have not yet been disclosed.

Additionally, the total reimbursement claims for Soliris this year, including all three indications, amount to 17.2 billion KRW (12,750 USD). If patients receive prescriptions as non-reimbursable items, they have to bear the cost themselves, which is in the 360 million KRW (266,765 USD) range annually. When the reimbursement is applied, the maximum out-of-pocket cost for patients is in the 10.5 million KRW (7,780 USD)range.