Lupin Ltd. and Yoshindo Inc. received approval to manufacture and sell a biosimilar version of Amgen Inc. and Pfizer Inc.'s blockbuster autoimmune disorder drug Enbrel, or etanercept, in Japan.
YL Biologics Ltd, a joint venture between Indian drugmaker Lupin and Japanese company Yoshindo, received the approval for YLB113 to treat moderate to severe rheumatoid arthritis and juvenile idiopathic arthritis. Biosimilars are lower-cost versions of biologic therapies.
The Japanese approval was based on data from a global phase 3 trial, which showed that YLB113 worked as well as Enbrel in treating rheumatoid arthritis, a disease which causes swelling and pain in the joints and even bones.
Lupin's Managing Director, Nilesh Gupta, said YLB113 was the company's first biosimilar to hit the market in Japan.
Amgen markets Enbrel in the U.S. and Canada, while Pfizer sells the medicine in the rest of the world.
Enbrel generated about $5.01 billion in 2018 sales for Amgen, down by about 8% from $5.43 billion in 2017. Pfizer sales for Enbrel amounted to $2.11 billion in 2018, down by about 14% from $2.45 billion in 2017.