Sandoz's Erelzi gains FDA approval for multiple inflammatory diseases
Erelzi, the first biosimilar etanercept that the FDA has approved, has now gained approval for all of the indications found in the reference product’s label.
Sandoz made this treatment as its second biosimilar that the FDA has approved through the Biologics Price Competition and Innovation Act.
"We continue to increase patient access to key treatment options by expanding our offering of biosimilars, which helps to reduce costs within the health care system," Carol Lynch, global head of biopharmaceuticals for Sandoz, said. “Sandoz is proud to have developed two of the three biosimilars that are currently FDA approved, which further demonstrates our commitment to U.S. patients in a growing number of therapeutic areas. We are committed to bringing Erelzi to the U.S. market as soon as possible.”
The new treatment passed with a unanimous vote of 20-0. Officials approved of the treatment after reviewing a comprehensive package featuring nonclinical, analytical and clinical data that show Erelzi is similar to the reference product that is licensed in the U.S.
Organizations in this story
Novartis Corporate Communications 230 Park Avenue, 21st Floor NY, NY 10169