Will create YL Biologics to focus on clinical development and commercialisation of biosimilars for Japan
Indian pharmaceutical company Lupin is to create a new biosimilars company in a joint venture with Japanese pharmaceuticals company Yoshindo.
The new company, to be called YL Biologics (YLB), will be jointly managed by both partners and will develop biosimilars including regulatory filings and obtain marketing authorisations in Japan, said Lupin.
YLB will in-license monoclonal antibodies (mAbs) from Lupin and also form partnerships with other companies across the globe for the Japanese market. Japan already has a clear cut regulatory regime in place for the development and commercialisation of biologicals.
'YLB is a reflection of Lupin's long-term commitment to the Japanese market and is an important first step forward to establishing Lupin's global biosimilar portfolio in Japan,' said Kamal Sharma, Vice Chairman of Lupin.
Lupin's autoimmune disease treatment Etanercept, developed by its Biotechnology Research Group in Pune, will be the first product to be licensed for clinical development to YLB.
This is an important first step forward to establishing Lupin's global biosimilar portfolio in Japan
Etanercept is a biopharmaceutical product approved globally for treating rheumatoid arthritis, psoriasis and ankylosing spondylitis.
The product is marketed as Enbrel in Japan by Takeda Pharmaceutical and had sales of US$496m in 2013.
Lupin will be entitled to milestone-based licensing income in addition to commercial supplies of the drug substance. The partners will then market the product under their own brand names to be sold by their respective sales networks, Lupin said.
The Japanese biological market is currently valued at roughly $12bn and is growing at 2–3% annually.
Commenting on the deal, Kenzo Shimomura, President, Yoshindo, said: 'YL Biologics is our bridgehead to expand Yoshindo's activities to the biosimilar market in Japan.
'We are very pleased to enter into a strong partnership with Lupin which will make it possible to jointly develop a meaningful biosimilar product pipeline for the Japanese market.'