Etanercept (also known as anti-TNF) is a drug that is used in the treatment of several auto immune diseases including rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and polyarticular juvenile idiopathic arthritis.
Etanercept can be prescribed by a consultant rheumatologist for:
- rheumatoid arthritis
- psoriatic arthritis
- ankylosing spondylitis
- juvenile idiopathic arthritis (JIA)
Etanercept in Japan
In June 2018, pharma giants Lupin and Nichi-Iko 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. The product will be launched by Nichi-Iko after receiving approval from the Pharmaceuticals and Medical Devices Agency (PMDA). The product will be developed by YL Biologics, a joint venture between Lupin’s subsidiary Lupin Atlantis Holdings SA (LAHSA) and Yoshindo.
In March 2018, Lupin’s Japanese subsidiary Kyowa had submitted a New Drug Application (NDA) to Japanese regulatory authorities post its successful Phase III study. 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. The ex-US market for Etanercept is estimated to be $4 billion in Japan and Europe, along with other regulated and emerging markets.
Helathcare Market Research