FDA Approves Second Biosimilar to Etanercept

Officials with the FDA have approved Samsung Bioepis’ biosimilar to etanercept (Enbrel, Amgen), the agency announced. Etanercept-ykro (Eticovo) is the second etanercept biosimilar to be approved by the FDA, following Sandoz’s etanercept-szzs (Erelzi) in 2016.¹

Etanercept-ykro was approved to treat all indications of the reference product, such as rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, and ankylosing spondylitis, according to the prescribing information¹.

The biosimilar was assessed in a phase 3 study comparing its safety and efficacy with the reference product in patients with moderate-to-severe RA despite methotrexate therapy. Patients were randomized to receive a weekly 50 mg dose of subcutaneous biosimilar or reference drug, with the primary endpoint being the American College of Rheumatology 20% (ACR20) response at week 24.²

Of the 596 study participants, the ACR20 response rate at week 24 was 78.1% for the etanercept biosimilar and 80.3% for the reference etanercept, according to the study. The 95% CI of the adjusted treatment difference was -9.41% to 4.98%, which is completely contained within the predefined equivalence margin of -15% to 15%, indicating therapeutic equivalence between the 2 drug products.²

The study also demonstrated that the biosimilar etanercept was well-tolerated with a lower immunogenicity profile and the safety profile was comparable with the reference product, according to the data.²

Etanercept-ykro has already been approved in other parts of the world, including its first approval in the Republic of Korea in 2015, followed by approvals in the European Union, Canada, Australia, and other markets in 2016, according to The Center for Biosimilars.³ It has also been approved under the names Benepali and Brenzys.

Despite being approved in 2016, Sandoz’s etanercept biosimilar has yet to be launched in the United States due to an ongoing legal battle with Amgen. No US launch date was specified for etanercept-ykro.

References

• FDA. Eticovo Prescribing Information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761066s000lbl.pdf?utm_campaign=FDA%20approves%20Eticovo%20%28etanercept-ykro%29%20biosimilar%20to%20Enbrel%20%28etanercept%29%20—%20Drug%20Information%20Update&utm_medium=email&utm_source=Eloqua. Accessed April 26, 2019.
• Emery P, Vencovsky J, Sylwestrzak A, et al. A phase 3 randomized, 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. 2017. 10.1136/annrheumdis-2015-207588
• Davio K. FDA Approves Samsung Bioepis’ Etanercept Biosmilar, Eticovo. The Center for Biosimilars. https://www.centerforbiosimilars.com/news/fda-approves-samsung-bioepis-etanercept-biosimilar-eticovo. Accessed April 26, 2019.