Aurobindo Pharma Expects First Biosimilar Approval In U.S. In 12-18 Months - (Bloomberg via NewsPoints Desk)

  • Aurobindo's managing director N Govindarajan said the Indian drugmaker expects its first biosimilar product to receive US approval in the next 12 months to 18 months, while it hopes to gain clearance in Europe by 2022, reported Bloomberg.

  • Last year, Aurobindo entered the biosimilar development space by acquiring four cell culture derived products from TL Biopharmaceutical, and is expanding its portfolio to eight more biosimilars.

  • "So far we have received approval for two products. It is a question of accumulation of approval before we start monetising, which can happen probably towards the end of this financial year," he said.

  • In regards to the company's plans on future buyouts, Govindarajan said "it would be more towards product opportunity for our branded division, but that would not be in the same scale of what we are doing now."

  • In September, Aurobindo's US subsidiary entered into an agreement to acquire commercial operations and three manufacturing facilities in the US from Novartis' Sandoz unit.

  • The acquisition will add around 300 products including projects in development as well as commercial and manufacturing capabilities in the US, the news source said.

To read more NewsPoints articles, click here.