Eye on Pharma: Lupin Submits Etanercept Biosimilar to Japanese Regulators

Lupin Pharmaceuticals has submitted a new drug application for its etanercept biosimilar, YLB113, in Japan, the company announced today. The application for marketing authorization for the drug for the indications of adult rheumatoid arthritis (RA) and juvenile idiopathic arthritis was filed in March 2018.

“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. This is an encouraging outcome as we make a strategic shift across Lupin to higher complexity products,” said Nilesh Gupta, managing director of Lupin.

In February of this year, Lupin and its partner, Yoshindo Inc, announced the successful completion of a global phase 3 clinical trial of the proposed etanercept biosimilar. The multinational, randomized, double-blind, 52-week controlled trial of the product was conducted in more than 500 patients with RA and compared the safety and efficacy of the proposed biosimilar with that of the reference product, Enbrel.

The study met its primary end point of equivalent improvement in RA, measured by American College of Rheumatology (ACR) criteria for 20% improvement (ACR20), at week 24, and the safety and immunogenicity of YLB113 were also similar to those of the reference Enbrel. Secondary end points for the trial included ACR50 and ACR70 (50% and 70% improvement, respectively) at weeks 4, 8, 12, and 24, as well as improvement in disease activity score using a count of 28 tender and swollen joints.

Also this year, Lupin announced that it plans to file for regulatory approval of the biosimilar etanercept in the first quarter of 2019 in Europe and in the third quarter of the 2020 fiscal year in the United States. Looking farther in Lupin’s biosimilar pipeline, a proposed ranibizumab product is currently in phase 1 clinical trials, while pegfilgrastim, filgrastim, denosumab, pertuzumab, and afliberept are all in early stages of development.