Lupin submits new drug application to sell biosimilar Etanercept in Japan - ( via NewsPoints Desk)

  • Lupin said on Tuesday that YL Biologics, Lupin's joint venture with Yoshindo, submitted a new drug application (NDA) before Japan's drug regulator to sell biosimilar of etanercept for treatment of rheumatoid arthritis, reported.
  • Etanercept, the biosimilar version of Pfizer's Enbrel, had global sales of $11 billion last year, according to the news source.

  • "With the application now filed, we are preparing to launch an affordable and high-quality biosimilar for consumers in Japan. This is an encouraging outcome as we make a strategic shift across Lupin to higher complexity products," said Nilesh Gupta, Lupin's managing director.

  • "After significant investment in our biotechnology R&D division over the years, this is the first biosimilar for regulated markets developed inhouse at Lupin and the first ever complex fusion protein like etanercept in regulated markets by an India pharmaceutical player," noted Cyrus Karkaria, president of Lupin Biotech.

  • Lupin said the filing opens up other key markets, such as Europe, Canada, Australia, the Middle East, South East Asia and Latin America, for its product within the next 12 months to 18 months.

  • Additionally, Lupin noted that it is on course with its plans for filing in the US and is targeting a filing in its full year 2019 to 2020.

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