European regulator to review Biocon's anti-cancer drugs
(6 months ago)
Bengaluru, Dec 1 : The European Medicines Agency accepted for review the marketing authorization applications of Biocon and its US partner Mylan for their cancer treatment drugs Trastuzumab and Pegfilgrastim, said the leading biotech firm on Friday.
"EMA's acceptance to review our applications on marketing Trastuzumab and Pegfilgrastim biosimilars is a welcome development, as they were resubmitted after taking corrective and preventive actions, including modifications of our drug making facility," said Biocon's Chief Executive Arun Chandavarkar in a statement here.
The pharma company hoped the regulator would verify its corrective actions during the inspection of its production facility soon as part of the review process.
"We will engage with the regulator to provide quality and affordable therapy options for cancer patients in Europe."