FDA Approves Nypozi, a Biosimilar to Neupogen
– Tanvex BioPharma, Inc. has announced that the U.S. Food and Drug Administration (FDA) approved the biologics license application (BLA) of Nypozi.
- Nypozi, proposed biosimilar to the reference product Amgen’s NEUPOGEN® – is indicated to
decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a significant
incidence of severe neutropenia with fever. - Tanvex’s Nypozi has been launched in Canada in January 2024.
