Lower-cost Soliris biosimilars launch in U.S.

USA – The first biosimilars of AstraZeneca’s (AZ) blockbuster C5 complement inhibitor Soliris (eculizumab) have officially launched in the United States, marking a significant milestone in expanding access to life-saving therapies for rare diseases.

Amgen’s Bkemv and Teva/Samsung Bioepis’ Epysqli, both approved by the FDA in 2023, are now available to treat paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and generalized myasthenia gravis (gMG).

These approvals cover all of Soliris’ FDA-approved indications except for neuromyelitis optica spectrum disorder (NMOSD), which is still protected by patent.

The U.S. launches were delayed due to patent litigation settlements despite earlier rollouts in Europe. Now, both biosimilars have entered the market at notable discounts.

Amgen has priced Bkemv at a 10% discount compared to Soliris, which carries a US $6,523 price tag per vial in the U.S. Meanwhile, Teva is offering Epysqli at a 30% discount, likely influenced by its current regulatory classification.

A key differentiator is that Bkemv is deemed interchangeable, allowing pharmacists to substitute it for Soliris without physician approval.

Epysqli’s interchangeability status will come into effect only after Bkemv’s 12-month exclusivity period ends.

Teva, which secured U.S. rights to Epysqli earlier this year, noted that 70% of PNH patients on Soliris are not dosed according to the label, and two-thirds discontinue within 1.5 years—largely due to high treatment costs.

These affordability concerns highlight the impact lower-cost biosimilars may have in improving treatment adherence and access.

Despite its dominance, Soliris is seeing declining revenue, falling 14% in 2024 to US $2.58 billion globally, with US $1.4 billion from the U.S.

It has been overtaken by Ultomiris (ravulizumab), a longer-acting C5 inhibitor from AZ, which brought in US $3.9 billion last year.

Both Soliris and Ultomiris were part of AZ’s US $39 billion acquisition of Alexion in 2021. The company is also building on its rare disease portfolio with Voydeya (danicopan), an oral Factor D inhibitor approved last year as an add-on for PNH patients with inadequate response to C5 therapy.

The launch of Bkemv and Epysqli ushers in a new era of competition in the high-cost rare disease space, with potential benefits for patients and payers alike.