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Lupin in partnership with Nichi-Iko

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An agreement was signed for the distribution, promotion and sale of Lupin’s recently-filed biosimilar Etanercept (YLB113) in Japan

Lupin and Nichi-Iko 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 and Yoshindo, the product will be launched by Nichi-Iko 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 authorisation 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 randomised 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.

Speaking about the partnership, Nilesh Gupta, MD, Lupin stated, “Etanercept is a key product as we build our biosimilars and complex generics pipeline. Our partnership with Nichi-Iko, takes us a step closer to the launch of our first in-house developed biosimilar that is used to combat a range of severe autoimmune disorders. The market for biologics in Japan is expected to reach $13.5 billion next year. The successful commercialisation of our first biosimilar will help our foray into the fast-growing biologics space and also provide patients in Japan access to a high-quality affordable alternative.”

“We at Nichi-Iko are pleased that this agreement will allow us to provide patients with our second biosimilar product, following Infliximab biosimilar. This will enable us to offer different treatment options that add value to the quality of life for our patients and their families,” said Yuichi Tamura, CEO, Nichi-Iko.

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.

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