Lupin, Nichi-Iko to commercialise arthritis biosimilar in Japan

Etanercept is used in treatment of auto immune diseases such as rheumatoid arthritis, plaque psoriasis, psoriatic arthritis and ankylosing spondylitis

Lupin Pharmaceuticals and Japan's Nichi-Iko have entered into a distribution, promotion and sale tie-up for Lupin's biosimilar Etanercept in Japan. Lupin had filed for this rheumatoid arthritis biosimilar recently. 

Biosimilars are copies of innovative biologic drugs and are made from living cells.

It has been developed by YL Biologics, a joint venture of Lupin Atlantis Holdings SA (LAHSA), a subsidiary of Mumbai-headquartered Lupin, and Yoshindo. Etanercept is used in the treatment of auto immune diseases including rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis among others. 

Nichi-Iko would launch the product after receiving approval from the Japanese regulator Pharmaceuticals and Medical Devices Agency (PMDA). Lupin's Japanese subsidiary Kyowa had submitted a New Drug Application (NDA) to the local authorities in March this year after it completed the global phase III study. Etanercept is a copy of Amgen's $11 billion drug Enbrel

Nilesh Gupta, MD Lupin Pharma, "The market for biologics in Japan is expected to reach $13.5 bn 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,” 

The company has indicated earlier that it plans to increase investments in its biotech business as it looks to build a pipeline of seven biosimilars with a total market size of $24 billion. 

“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.