Pharma major Lupin and Nichi-lko announced that the two companies have entered into an agreement for the distribution, promotion and sale of Lupin's recently-filed biosimilar Etanercept (YL5113) in Japan.

Developed by YL Biologics, a joint venture between Lupin's subsidiaryLupin Atlantis Holdings SA(LAHSA) and Yoshindo, the product will be launched by Nichi-lko after receiving approval from the Pharmaceuticals and Medical Devices Agency (PMDA).

Kyowa (Lupin's subsidiary in Japan) had submitted a New Drug Application (NDA) for Marketing Authorization to the Pharmaceuticals and Medical Devices Agency (PMDA) in March this year following the successful conclusion of its global Phase III study. The study was a multinational randomized double-blind controlled trial of 52 weeks duration which included more than 500 patients with rheumatoid arthritis (RA) in 11 countries. It compared YLB113's efficacy and safety directly against Enbrel of Amgen/Pfizer. The study was conducted at 110 rheumatology clinics across Japan, Europe and India. This study included over 260 Japanese patients from 62 rheumatology clinics, a scale that is unique fora global RA trial for Japan.

Nilesh Gupta, Managing Directorof Lupin, stated "Etanercept isa key product as we build our biosimilars and complexgenerics pipeline. Our partnership with Nichi-lko, takes us a step closerto the launch of our first in-house developed biosimilar that is used to combat a range of severe autoimmune disorders. The marketfor biologics in Japan is expected to reach USD 13.5 billion next year. The successful commercialization of ourfirst biosimilar will help ourforay into the fast-growing biologics space and also provide patients in Japan accessto a highquality affordable alternative."

Shares of the company declined Rs 13.45, or 1.48%, to trade at Rs 896.95. The total volume of shares traded was 98,363 at the BSE (11.25 a.m., Monday).