The European Medicines Agency has accepted for review Lupin’s marketing authorization application seeking approval to market the company’s biosimilar therapy of etanercept, called YLB113.
Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis are among the indications targeted for the approval of YBL113.
Amgen’s etanercept — sold under the brand name Enbrel — is one of the first anti-tumor necrosis factor (TNF) biologic therapies developed and approved to treat severe arthritis. The therapy is indicated for the treatment of long-term inflammatory conditions, including rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis.
A biosimilar is a medicine highly similar to another, already approved medicine (the “reference medicine”). The biosimilar has the same therapeutic activity, safety, and quality as the reference medicine, but it can only be produced once the reference medicine loses its patent exclusivity.
The safety and effectiveness of YLB113 was evaluated and compared with that of Enbrel in a global Phase 3 trial (2015-002809-12) that enrolled more than 500 rheumatoid arthritis patients across Japan, Europe, and India. It included more than 230 patients from Europe.
Participants were randomized to treatment with Enbrel or YLB113 for up to 52 weeks.
Results showed that treatment with YLB113 resulted in significant improvements of at least 20% in disease activity, measured according to the American College of Rheumatology 20 response rate.
Patient response to YLB113 was equivalent, and within a predefined acceptable variability range, to the Enbrel-treated group. Safety and tolerability profiles, as well as the autoimmune reactivity profile, of the biosimilar were also found to be similar to Enbrel.
“The application for our Etanercept biosimilar and its acceptance in Europe is a significant milestone for our foray into biosimilars in key developed markets. This is also an encouraging development as we continue building our pipeline of higher complexity products,” Nilesh Gupta, managing director of Lupin, said in a press release.
“Etanercept (YLB113) is the first biosimilar developed in-house by Lupin and this makes us the first Indian pharmaceutical company to file for a complex fusion protein like Etanercept in regulated markets,” said Cyrus Karkaria, PhD, Lupin’s president of biotechnology.
“This is a significant step in the fight against severe auto-immune disorders that calls for an effective, affordable equivalent for patients across Europe. Lupin has made significant investments in the biosimilars space over the last decade, and this application is an important achievement for us in our journey for future developments in biologics,” he said.
Earlier this year, YLB113 was submitted for approval to the Japanese Pharmaceuticals and Medical Devices Agency as a treatment for moderate to severe rheumatoid arthritis and juvenile idiopathic arthritis.
Lupin plans to seek approval of YLB113 with the U.S. Food and Drug Administration by 2020.