Jun 18: Mumbai-based pharma major Lupin Ltd and Japan-based Nichi-Iko on Monday announced that the two companies 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-Iko after receiving approval from the Pharmaceuticals and Medical Devices Agency (PMDA).
According to Lupin, 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 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.
Speaking about the partnership, Nilesh Gupta, Managing Director of Lupin Ltd, said, “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 Bn next year. The successful commercialization 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 very 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 of Nichi-Iko.
Meanwhile, 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, according to Lupin.