Pharma firms Lupin and Nichi-Iko said today that they have entered into a pact for the distribution, promotion and sale of Lupin's biosimilar drug Etanercept in Japan.
The drug is used for treatment of rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and polyarticular juvenile idiopathic arthritis.
Developed by YL Biologics, a joint venture between the company's arm Lupin Atlantis Holdings SA and Yoshindo, the product will be launched by Japan's Nichi -Iko after receiving approval from the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan, Lupin said in a filing to BSE.
Lupin's subsidiary, Kyowa had submitted a New Drug Application (NDA) for marketing authorisation to the PMDA in March this year following the successful conclusion of its global phase III study, it added.
Lupin MD Nilesh Gupta said: "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."
Nichi-Iko CEO Yuichi Tamura said: "We at Nichi-Iko are very pleased that this agreement will allow us to provide patients with our second biosimilar product, following Infliximab biosimilar."
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