Tanvex has announced that the FDA has approved its Nypozi® (TX01), biosimilar to Amgen’s Neupogen® (filgrastim). Nypozi® is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a significant incidence of severe neutropenia with fever.
In December 2019, Tanvex and Amgen settled US litigation brought by Amgen in relation to Tanvex’s filgrastim biosimilar.
The first filgrastim biosimilars approved in Europe were Ratiograstim and Tevagrastim in 2009. Soon after, Hospira’s filgrastim biosimilar was approved in Australia in 2010. Sandoz’s Zarxio was approved in the US in March 2015. It is interesting to see new biosimilars still being approved over 20 years later.