Hyderabad: Lupin Ltd., India’s third largest drug maker plans to file its first biosimilar, etanercept, for approval in Japan, the world’s second largest market for medicines next year. This will be followed by Europe and the US, as it tries to catch up with other Indian rivals like Biocon Ltd and Dr.Reddy’s Laboratories Ltd who had the first mover advantage.
Biosimilars are copies of complex biological drugs made from living cells and cannot be identically replicated.
Etanercept is the biosimilar version of US-based Amgen Inc.’s drug Enbrel with global sales of $5.36 billion. It is used to treat five chronic inflammatory conditions, including rheumatoid arthritis and plaque psoriasis.
“It (etanercept) is in phase-III trial – plan is to be able to file next year for Japan, Europe and still need to talk to (US) FDA (Food and Drug Administration),” said Nilesh Gupta, managing director of Lupin in a telephone interview.
Gupta said his company is developing a pipeline of four biosimilars focussed on regulated markets, without disclosing specific details of those products and timelines.
Lupin formed a joint venture with Japan-based Yoshindo Inc. two years ago to handle clinical trials, regulatory filings and obtain marketing authorizations for certain biosimilars including etanercept in Japan.
Lupin is currently one of the largest generic drug companies in Japan.
The global biosimilar market is predicted to have sales of $25 billion by 2020, according to a 2014 Thomson Reuters report. Developed markets account for a lion’s share.
