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Nichi-Iko to sell Lupin’s biosimilar drug in Japan

Nichi-Iko to sell Lupin’s biosimilar drug in Japan

New Delhi: Pharma firms Lupin and Nichi-Iko said that they have entered into a pact for the Japan, promotion, and sale of Lupin’s biosimilar drug Etanercept in Japan.

The drug is used for the 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 authorization 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.”

Etanercept is a key product as the company build its biosimilars and complex generics pipeline, he added.

“The market for biologics in Japan is expected to reach USD 13.5 billion 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,” Gupta said.

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.”

Lupin has it has also submitted the marketing authorization application (MAA) for its Etanercept biosimilar to the European Medicines Agency (EMA).

Source: PTI
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