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.
  1. 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.
  2. 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
  3. 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.

Stay up to date on the latest news in specialty pharmacy by getting Specialty Pharmacy Times in your mailbox or inbox for free!

Click here to sign up for free for the bi-monthly Specialty Pharmacy Times print journal delivered to your address.

Click here to sign up for our email newsletters delivered every Monday, Wednesday, and Friday, in addition to breaking news alerts.

Click here to follow us on Facebook. 

Click here to follow us on Twitter. 

Click here to join our LinkedIn group. 

Related Articles

Rituximab-pvvr (Ruxience, Pfizer) is approved for the treatment of non-Hodgkin lymphoma, chronic lymphocytic leukemia, and granulomatosis with polyangiitis and microscopic polyangiitis.
Pfizer’s bevacizumab-bvzr (Zirabev) demonstrated clinical equivalence and no clinically meaningful differences compared with the reference product.
Top news of the day from across the health care landscape.
Company Profile >
Industry Guide >
Market News >
Peer Exchange >
Conferences >
Subscribe >
Specialty Times Resources
About Us
Contact Us
Terms & Conditions
MJH Associates >
Pharmacy Times
American Journal of Managed Care
MD Magazine
Targeted Oncology
Physicians' Education Resource
Pharmacy & Healthcare Communications, LLC
2 Clarke Drive
Suite 100
Cranbury, NJ 08512
P: 609-716-7777
F: 609-716-4747

Copyright Specialty Pharmacy Times 2006-2019
Pharmacy & Healthcare Communications, LLC. All Rights Reserved.