New Delhi: Lupin Ltd, India’s third-largest drug maker, on Monday said it has tied up with Japan’s Nichi-Iko for the distribution, promotion and sale of Lupin’s recently filed biosimilar Etanercept in Japan.
Etanercept is used for the treatment of several auto immune diseases. According to Lupin, the market for biologics in Japan is expected to reach $13.5 billion next year.
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), the Japanese regulator.
Lupin said its Japanese subsidiary Kyowa had submitted a New Drug Application (NDA) for marketing authorisation to PMDA in March this year following the successful conclusion of its global Phase III study at 110 rheumatology clinics across Japan, Europe and India.
According to Nilesh Gupta, managing director of Lupin Ltd, “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.”
Lupin, which has just made an entry into biosimilars, has also submitted the Marketing Authorisation Application (MAA) for its Etanercept biosimilar to the European Medicines Agency (EMA), in addition to Japan. Lupin’s biosimilar Etanercept is targeted at treating rheumatoid arthritis (RA), psoriatic arthritis, ankylosing spondylitis, axial spondyloarthritis, non-radiographic axial spondyloarthritis and plaque psoriasis.
Etanercept, the biosimilar version of Pfizer’s Enbrel, had global sales of $11 billion in 2017. It was the first TNF biologic treatment to be FDA approved in 1998. It was approved to treat moderate to severe RA, and is used in the treatment of five long-term inflammatory conditions. The ex-US market for Etanercept is estimated at $4 billion in Japan and Europe, along with other regulated and emerging markets.
“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, chief executive officer of Nichi-Iko.