Etanercept Biosimilar Approved for RA and Other Conditions

June 7, 2019

In April, the FDA approved the etanercept biosimilar etanercept-ykro (Eticovo, Samsung Bioepis) for the same indications as its reference product Enbrel.

In April, the FDA approved the etanercept biosimilar etanercept-ykro (Eticovo, Samsung Bioepis) for the same indications as its reference product Enbrel. These include: rheumatoid arthritis, polyarticular juvenile idiopathic arthritis (JIA) in patients 2 years and older; psoriatic arthritis, ankylosing spondylitis and plaque psoriasis in patients 4 years and older.

A phase three trial of 596 rheumatoid arthritis patients found the biosimilar was equivalent to its reference product, etanercept, in terms of efficacy at 24 weeks. Of 299 patients assigned the biosimilar, 78.1 percent achieved ACR20 at 24 weeks as compared to 80.3 percent of 297 etanercept recipients.

Adverse events were equally comparable with 55.2 percent for the biosimilar and 58.2 percent for etanercept. Of note, the incidence of anti-drug antibody development by week 24 was 0.7 percent for the biosimilar as compared with etanercept at 13.1 percent.

This is the second etanercept biosimilar. The first, etanercept-szzs (Erelzi, Sandoz) was approved in 2016, but has not yet launched due to ongoing litigation with Amgen, the maker of the reference product etanercept (Enbrel).

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REFERENCE

  • Paul Emery, Jiří Vencovský, Anna Sylwestrzak, 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," Annals of the Rheumatic Diseases, July 6, 2015. DOI:10.1136/annrheumdis-2015-207588