The agreement will create a new entity, YL Biologics, which will be jointly managed by both Lupin and Yoshindo, and will be responsible for conducting clinical development of biosimilars, including regulatory filings and obtaining marketing authorizations in Japan.

YL Biologics will in-license monoclonal antibodies from Lupin, starting with Lupin’s etanercept biosimilar. The drug is a biosimilar of Amgen’s blockbuster autoimmune disease treatment Enbrel (etanercept). Enbrel is a tumour necrosis factor (TNF) inhibitor that is approved to treat rheumatoid, juvenile rheumatoid and psoriatic arthritis, plaque psoriasis and ankylosing spondylitis. Enbrel is marketed in Japan by Takeda Pharmaceutical and had sales of US$496 million in Japan for 2013, according to IMS Health.

YL Biologics will also partner with other companies across the globe for the Japanese market. The Japanese biologicals market is currently valued at around US$12 billion and is growing at 2–3% annually. Monoclonal antibodies make up US$3.5 billion of overall Japanese biologicals sales, with growth of 5%, according to IMS Health.

As part of the agreement Lupin will be entitled to milestone payments and both Lupin and Yoshindo will market any products produced by the joint venture under their own brand names.

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