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Lupin To File Its First Biosimilar In Japan, EU In 2019

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Lupin Ltd. plans to file an application for its biosimilar Etanercept with regulators in Europe and Japan in 2019 following positive results displayed by the product in phase-III clinical trials.

The drug has been developed by YL Biologics, a joint venture between Lupin and Japanese pharma company Yoshindo. The drug is a copy of drugmaker Amgen’s Enbrel, the first such biosimilar with a market size of $11 billion. The patent for the drug expired in October 2012, except in the United States where Amgen won a new patent to market it for another 17 years.

Lupin plans to launch the drug in Japan and Europe by 2020. The launch in the United States will, however, be delayed because of the ongoing patent battle between pharma companies Amgen and Merck. “We will wait for the dust to settle in the U.S. market and will probably consider filing by 2020,” Dhananjay Bakhle, executive vice president of Medical Research at Lupin told BloombergQuint in an interview.

The company has a global pipeline of seven biosimilars, of which two, Filgrastim and Pegfilgrastim have already been launched in India. These two drugs will be filed with the USFDA by fiscal 2019. The other opthalmology biosimilar Ranibizumab will also be filed with the U.S. and European regulator by fiscal 2021, according to a presentation released by Lupin.

The total biosimilar target market size is worth $30 billion for the company.

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