YL Biologics in collaboration with Kyowa, a subsidiary Lupin, are seeking approval from regulatory officials in Japan of YLB113, their potential treatment for patients with moderate-to-severe juvenile idiopathic arthritis and rheumatoid arthritis.
YLB113 is a novel biosimilar formulation of Amgen and Pfizer’s Enbrel (etanercept), one of the first anti-TNF biologic therapies developed and approved to treat severe rheumatoid arthritis.
“The application for Etanercept biosimilar is a significant milestone for Lupin as we build our biosimilars pipeline. With the application now filed, we are preparing to launch an affordable and high-quality biosimilar for consumers in Japan,” Nilesh Gupta, MBA, managing director of Lupin, said in a press release.
The therapeutic activity of YLB113 was evaluated and compared to that of Enbrel in a global Phase 3 trial (2015-002809-12). The study included more than 500 rheumatoid arthritis patients across 11 countries, of whom over 260 participants were followed in 62 rheumatology clinics in Japan. Patients were randomized to treatment with Enbrel or YLB113 for up to 52 weeks.
Results showed that treatment with YLB113 induced significant clinical improvements, as measured by the American College of Rheumatology 20 (ACR20) response rate — meaning an improvement of at least 20% in disease activity, the companies reported in February. This response was found to be equivalent, and within a pre-defined acceptable variability range, to that reported in the Enbrel-treated group.
The biosimilar’s safety and tolerability profiles, as well as its autoimmune reactivity, were also found to be similar to Enbrel.
These data supported the filling of a New Drug Application with the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for YLB113 as an Enbrel biosimilar. The companies are seeking marketing authorization for YLB113 to treat moderate-to-severe rheumatoid arthritis and juvenile idiopathic arthritis.
“Etanercept [Enbrel] is used globally in the fight against a range of severe autoimmune disorders. The successful filing and eventual approval of YLB113 is a major step in the fight against these diseases, and will allow access to an effective, affordable equivalent,” said Cyrus Karkaria, PhD, president of Lupin Biotech.
If successful, Lupin anticipates further requests to make YLB113 available to patients worldwide. The company is planning to pursue regulatory approval in markets including Europe, Canada, Australia, the Middle East, Southeast Asia, and Latin America within the next 12 to 18 months.
Lupin plans to seek approval of YLB113 with the U.S. Food and Drug Administration by or before 2020, the press release states.