FDA approves Eticovo, second Enbrel biosimilar
The FDA has approved the second biosimilar to etanercept, etanercept-ykro, for all eligible indications of the biologic product, according to an FDA press release.
Eticovo (etanercept-ykro, Samsung Bioepis), a biosimilar to Enbrel (etanercept, Amgen), is a TNF-inhibitor intended to treat patients with ankylosing spondylitis, plaque psoriasis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis and rheumatoid arthritis.
With this approval, Eticovo becomes the second biosimilar to Enbrel approved for use in the United States, following Erelzi (etanercept-szzs, Sandoz) in 2016 — a product that has yet to launch in the U.S. due to the ongoing legal battle between Amgen and Sandoz.
“The approval of Eticovo adds to our growing portfolio of anti-TNF medicines in the USA, where we believe biosimilars can bring meaningful value to the country’s healthcare system,” Christopher Hansung Ko, PhD, president and CEO of Samsung Bioepis, said in a press release. “Through relentless process innovation and an uncompromising commitment to quality, we remain dedicated to advancing one of the industry’s strongest biosimilar pipelines.”
The FDA based its approval on a 24-week randomized, double-blind phase 3 trial comparing the safety and efficacy of Eticovo against the reference product among patients with moderate to severe rheumatoid arthritis despite treatment with methotrexate.
According to study results, Eticovo demonstrated equivalence of efficacy to the reference product and its safety was determined to be generally comparable to etanercept. Although treatment-emergent adverse events were found to be similar between Eticovo (55.2%) and the reference product (58.2%), the incidence of antidrug antibodies at week 24 was markedly lower in the Eticovo group (0.7%) compared with the reference product group (13.1%).
Eticovo is the third biosimilar product from Samsung Bioepis to be approved in the U.S., following Renflexis (infliximab-abda) in 2017 and Ontruzant (trastuzumab-dttb) earlier this year.
“With the third biosimilars approved in the U.S., the company has once again demonstrated its global R&D capability,” Ko said. “We will continue to work to ensure that more patients have the opportunity to use high-quality biopharmaceuticals at a reasonable price.”