Lupin's JV completes global trials for RA biosimilar - (The Economic Times via NewsPoints Desk)

  • Lupin announced that YL Biologics, a joint venture with Yoshindo, has successfully completed late-stage studies of a biosimilar of Amgen and Pfizer's Enbrel, as reported The Economic Times Wednesday.

  • In the study of more than 500 patients, YLB 113 displayed non-inferiority to Enbrel.

  • "Biosimilars are a big part of the generic story going forward," commented Lupin managing director Nilesh Gupta, adding "the successful completion of our Phase III trial of [the Enbrel] biosimilar marks an important milestone in our biologics journey."

  • "We will be filing for the regulatory approval for YLB 113 in Q1 of FY 19 in Japan and EU and by Q1 or Q2 of FY 19 in India," noted Lupin biotechnology division president Cyrus Karkaria.

  • Karkaria said a US filing could occur within a year to 18 months after its Japanese and Indian filings.

  • FirstWord Reports: Providing insight, analysis and expert opinion on important Pharma trends and challenging issues <Click here>

To read more NewsPoints articles, click here.

Reference Articles