Lupin to file application for biosimilar etanercept in EU, Japan in next quarter
Mumbai: Lupin Ltd plans to file an application for its biosimilar Etanercept with regulators in Europe and Japan during the next quarter following positive results displayed by the product in phase-III clinical trials.
YL Biologics, a joint venture of Lupin and Japanese firm Yoshindo, which has developed the biosimilar, said on Wednesday that phase-III trial of Etanercept, conducted on more than 500 patients with rheumatoid arthritis in 11 countries, met the primary endpoint and the product’s safety and immunogenicity was found to be similar to the reference drug Enbrel.
The study was conducted at 110 rheumatology clinics across Japan, Europe and India. This study included over 260 Japanese patients from 62 rheumatology clinics, a scale that is distinct for a global trial.
Etanercept will be the company’s first biosimilar product for the global market. The market size for the innovator’s product Enbrel is $11 billion.
“We are excited by the positive results from the Phase-III trial. This helps us put together a robust regulatory dossier intended for global regulatory filings,” said Nilesh Gupta, managing director of Lupin.
The regulatory filing for biosimilar Etanercept in the US market is expected during the fiscal year 2019-20, Dhananjay Bakhle, executive vice president, medical research at Lupin told Mint.
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