Lupin in Japanese tie-up for biologics

Drugmaker Lupin Ltd has entered into a joint venture agreement with Japanese pharmaceuticals company Yoshindo Inc to create a new entity, YL Biologics (YLB).

YLB will be jointly managed by both partners and will be responsible for conducting clinical development of certain biosimilars including regulatory filings and obtaining marketing authorisations in Japan, Lupin said.

The new entity YLB will in-license monoclonal antibodies (mAbs) from Lupin and also partner with other companies across the globe for the Japanese market which already has a clear cut regulatory regime in place for the development and commercialisation of biologicals.

Lupin’s Etanercept biosimilar, developed by its biotechnology research group in Pune will be the first product to be licensed for clinical development to YLB. Etanercept is a biopharmaceutical product approved globally for treating autoimmune diseases such as rheumatoid arthritis, psoriasis and ankylosing spondylitis. Originally sold as Enbrel, the drug is marketed in Japan by Takeda Pharmaceutical and has a sales of $496 million, up to March 2013.

The Japanese biological market is valued at about $ 12 billion and growing at three per cent annually. And monoclonal antibodies account for about $3.5 billion of the overall Japanese biological sales, growing at 5 per cent.

Lupin will be entitled to milestone based licensing income in addition to commercial supplies of the drug substance, Lupin sid. Both Lupin and Yoshindo will then market the product under their own brand names by leveraging their respective sales networks. Business Line