Jointly managed by both companies, YLB will in-license monoclonal antibodies from Lupin and partner with other companies in order to develop biosimilars for regulatory filings and to obtain marketing authorizations in Japan.
“Lupin would be responsible for not only developing the pipeline but also supplying the drug substance for the mAbs in question,” Lupin spokeswoman Shamsher Gorawara told us.
India-based Lupin's Enbrel (etanercept) biosimilar, developed by its Biotechnology Research Group in Pune, India, will be the first product to be licensed for clinical development to YLB. Enbrel, which is used to treat rheumatoid arthritis and other conditions, is currently marketed in Japan by Takeda Pharmaceutical and had sales of $496m in 2013.
Kamal Sharma, Vice Chairman of Lupin said, "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."
Lupin will be entitled to milestone based licensing income in addition to commercial supplies of the drug substance. Both Lupin and Yoshindo will then market the product under their own brand names by leveraging their respective sales networks.
Commenting on the JV, Kenzo Shimomura, president of Yoshindo, said, "YL Biologics Ltd. is our bridgehead to expand Yoshindo's activities to the biosimilar market in Japan and highlight on the strategic representation of company. 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.”
The Japanese biologics market is currently valued at close to $12bn and is growing 2-3% annually. Monoclonal antibodies make up $3.5bn of the overall biologics sales in the country and are growing at 5%, according to IMS Health.
YLB seems confident on the market, with Gorawara adding, “We really don’t see challenges given the clear regulatory pathway for mAbs in Japan other than the usual which would be what one comes up with in terms of trials and compliance not to mention competition once YLB starts getting approvals.”