FDA Approves Samsung Bioepis' Etanercept Biosimilar, Eticovo

The FDA has approved Samsung Bioepis’ etanercept biosimilar, SB4, as Eticovo (etanercept-ykro). A representative from Samsung Bioepis has confirmed approval of the product to The Center for Biosimilars® in an email. The biosimilar is already approved in a variety of other markets under the name Benepali.
Kelly Davio
April 26, 2019
This story has been updated.

The FDA has approved Samsung Bioepis’ etanercept biosimilar, SB4, as Eticovo (etanercept-ykro). Before the FDA announced this development, a representative from Samsung Bioepis confirmed approval of the product to The Center for Biosimilars® in an email.

The biosimilar was approved to treat all indications of its reference, Enbrel: rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, and ankylosing spondylitis.

Samsung Bioepis’ biosimilar is already approved in a variety of other markets under the names Benepali and Brenzys. The biosimilar earned its first approval in the Republic of Korea in 2015, followed by approvals in the European Union, Canada, Australia, and other markets 2016. Worldwide, the biosimilar was responsible for $124 million in sales last quarter.

The biosimilar was assessed in a phase 3 study versus the reference Enbrel in patients with RA that was not well controlled despite treatment with methotrexate.1 In the trial 596 patients were randomized to receive either the biosimilar (n = 299) or the reference (n = 297).

The percentage of patients who achieved an American College of Rheumatology 20% improvement (ACR20) was 78.1% in the biosimilar arm and 80.3% in the reference arm. The 95% confidence interval of the adjusted treatment difference was −9.41% to 4.98%, which was fully contained within the prespecified equivalence margin (−15% to 15%).

Treatment-emergent adverse events were comparable between arms (55.2% versus 58.2%), but the incidence of antidrug antibodies at week 24 was notably lower in the biosimilar arm (0.7%) than in the reference arm (13.1%).

At week 52, ACR20 response rates in the per-protocol set were comparable between biosimilar arm (80.8%) and reference arm (81.5%) and were maintained up to week 52.2 Radiographic progression was also comparable, and the change from baseline in modified total Sharp score was 0.45 for the biosimilar and 0.74 for the reference. The incidence of antidrug antibodies remained lower in the biosimilar arm (1.0%) than the reference arm (13.2%).

Observational studies have also reported patient satisfaction with self-administration of the biosimilar in a prefilled pen, and the biosimilar has been the subject of numerous real-world studies that have shown that nonmedical switching to the drug did not negatively impact disease measures, though other studies have reported that patients who started treatment with the biosimilar had higher retention than those who switched from the reference drug.

Eticovo is the second biosimilar etanercept approved by the FDA; the first was Sandoz’s Erelzi, which has been the subject of lengthy litigation with Enbrel’s sponsor, Amgen. Despite having been approved in 2016, Erelzi has not yet launched in the United States, and it is unlikely to do so until legal issues have been resolved.

No launch date has been announced for Eticovo.

Reference
1. Emery P, Vencovsky J, Sylwestrzak A, et al. A phase III randomised, double-blind, parallel-group study comparing SB4 with etanercept reference product in patients with active rheumatoid arthritis despite methotrexate therapy. Ann Rheum Dis. 2017;76(1):51-57. doi: 10.1136/annrheumdis-2015-207588.

2. Emery P, Vencovsky J, Sylwestrzak A, et al. 52-week results of the phase 3 randomized study comparing SB4 with reference etanercept in patients with active rheumatoid arthritis. 2017;56(12):2093-2101. Rheumatology (Oxford). doi: 10.1093/rheumatology/kex269.

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