FDA to review Mylan, Biocon’s biosimilar to Amgen’s cancer treatment Neulasta, announcing competition to slightly decreasing market
February 16, 2017The U.S. Food and Drug Administration (FDA) has accepted Mylan’s Biologics License Application (BLA) for multiple types of cancer treatment MYL-1401H, a proposed biosimilar to Amgen’s Neulasta. This is the second BLA accepted for review by FDA as part of the Mylan and Biocon partnership within the past two months.
The proposed biosimilar to Neulasta is used to reduce the duration of neutropenia (low count of neutrophils, a type of white blood cells) and the incidence of fever associated with neutropenia in adult patients treated with chemotherapy in certain types of cancer.
Amgen said in its full year and fourth quarter financial results that Neulasta sales decreased 3 percent for the fourth quarter and 1 percent for the full year, citing lower unit demand. It sold for $943M in the USA in the q4 2016, and $173M in the rest of the world. Sales from the Neulasta brought $4,648 million to Amgen in 2016.
Mylan’s President Rajiv Malik said: “The milestone builds upon the acceptance of regulatory filings for proposed biosimilar pegfilgrastim in Europe, Australia, and Canada and reinforces our dedication and commitment to establishing a global platform for this product.”
Dr. Arun Chandavarkar, CEO and Joint Managing Director, Biocon, said: “Once approved, our proposed biosimilar pegfilgrastim will provide a high quality alternative to branded pegfilgrastim (Neulasta) for cancer patients during cytotoxic chemotherapy.”
