SEBI Reg. Investment Advisor

Download App

MoneyWorks4Me

Lupin, Nichi-Iko enter into agreement for commercialization of biosimilar Etanercept in Japan

18 Jun 2018 Evaluate

Lupin and Nichi-lko have entered into an agreement for the distribution, promotion and sale of Lupin's recently-filed biosimilar Etanercept (YLB113) in Japan. Developed by YL Biologics, a joint venture between Lupin's subsidiary Lupin 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 for a global RA trial for Japan.

In addition to Japan, Lupin has also submitted the Marketing Authorization Application (MAA) for its Etanercept biosimilar to the European Medicines Agency (EMA). The indications targeted for approval are Rheumatoid Arthritis (RA), Psoriatic Arthritis, Ankylosing Spondylitis, Axial spondyloarthritis, Non-radiographic Axial Spondyloarthritis and Plaque Psoriasis. The ex-US market for Etanercept is estimated at $4 billion in Japan and Europe, along with other regulated and emerging markets.

Lupin Share Price

2516.90 27.05 (1.09%)
08-Jul-2026 09:27 View Price Chart
Peers
Company Name CMP
Sun Pharma. Inds. 1921.35
Dr. Reddys Labs. 1371.45
Cipla 1465.90
Zydus Lifesciences 1176.20
Lupin 2516.90
View more..

About MoneyWorks4Me

MoneyWorks4Me is a SEBI-registered Investment Adviser (IA) dedicated to helping investors build long-term wealth through transparent, research-driven, conflict-free guidance. Founded in 2008, we started our journey as a Research Analyst (RA), providing deep fundamental analysis, intrinsic value insights, and long-term investing frameworks for Indian equities. In 2017, we transitioned to a full-fledged SEBI-registered Investment Adviser, strengthening our commitment to acting as a fiduciary—always putting the investor’s interest first.

Our Vision

To become India’s most trusted, research-powered fiduciary advisory platform—where every investor, regardless of experience, can make calm, confident, and well-reasoned investment decisions.

What Makes MoneyWorks4Me Different

Our Approach: Ensuring compounding work its magic on client portfolio.

MoneyWorks4Me ensures this through: