FDA approval of Amgen’s granulocyte colony-stimulating factor for treatment of acute radiation syndrome carries seven years of orphan product exclusivity, which may keep the indication off the label of Sandoz’s biosimilar.

Teva is the first company to get FDA approval of a version of Amgen’s Neupogen; one biosimilar expert questions why Teva did not switch its BLA to a biosimilar application when that pathway became available.

US FDA considering approach that is similar to, but more stringent than, influenza strain changes, CBER Director Marks says. Meanwhile, vaccine developers face challenge of when to change antigens to get the best results, NIH’s Graham notes. As FDA and sponsors gain more experience with tweaking the vaccines to account for new coronavirus variants and strains, the process may be expedited further.