Mumbai, April 23: Drug maker Lupin has entered into a joint venture agreement with Yoshindo Inc, a Japanese pharmaceutical company, to form a new entity that will be responsible for the development of biosimilar products and obtain access to the Japanese market.
The joint venture entity — YL Biologics (YLB) — will be jointly managed by both the partners and responsible for conducting the clinical development of certain biosimilars, including regulatory filings.
A biosimilar is like an original biologic (molecule derived from living cells) drug developed after the patent expiry of the latter.
The joint venture with Yoshindo is part of Lupin’s efforts to penetrate fast growing markets. In this direction, it had acquired Laboratorios Grin of Mexico in March.
Sources said Lupin was also targeting lucrative niche segments such as inhalers, valued at over $23 billion in sales annually. The company had acquired Nanomi BV in the Netherlands and plans to set up a dedicated inhalation research facility as well as one for complex injectables in the US.
“We are very excited about the joint venture with Yoshindo, a partner who shares our commitment to bringing biosimilars to the market in Japan. YLB is a reflection of Lupin’s long-term commitment to the Japanese market and is an important first step towards establishing Lupin’s global biosimilar portfolio,” Lupin’s vice chairman Kamal K. Sharma said.
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 auto-immune diseases such as rheumatoid arthritis and psoriasis.
The biotechnology group at Lupin has created and developed a basket of 10 biosimilars, which are now in various stages of development. These biosimilars address various therapy areas such as oncology, inflammation, anti-virals, osteoporosis and rheumatoid arthritis. Lupin has received approvals from Indian authorities to market two of these products.
“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,” the Mumbai-based company added.
While Japan has been one of the key focus markets for Japan, the biological market there is currently valued at close to $12 billion and growing at 2-3 per cent annually.
Established in 1962, Yoshindo Inc has revenues of over $350 million and is among the top five generic pharmaceutical corporations in Japan.