logo
Plus   Neg
Share
Email

Sandoz Resubmits BLA For Proposed Biosimilar Pegfilgrastim To FDA - Quick Facts

Sandoz, a Novartis division, announced resubmission of its Biologics License Application (BLA) for a proposed biosimilar pegfilgrastim to the US FDA to address an FDA complete response letter received in June 2016. The resubmission includes new data from a pivotal pharmacokinetics and pharmacodynamics study.

Sandoz said it is pursuing approval of biosimilar pegfilgrastim to decrease the incidence of infection, as manifested by febrile neutropenia (low white blood cell count with a fever), in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. The company said the new data was from a single-dose, three-period cross-over study comparing Sandoz pegfilgrastim with US-sourced reference pegfilgrastim; Sandoz pegfilgrastim with EU-sourced reference pegfilgrastim; and US with EU-sourced reference pegfilgrastim.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Walmart (WMT) on Wednesday announced that it is teaming up with Capital One to roll out two new credit cards designed to compete with cards from Apple and Amazon. The companies said the Capital One Walmart Rewards Credit Card Program with two new cards will launch on September 24. The program's Mastercard... Chipotle Mexican Grill Inc. is introducing a new protein to its menu, Carne Asada, starting this week. Carne Asada is Chipotle's newest protein addition since it reintroduced chorizo in September 2018. The Mexican food chain said that the new steak option will be available at its restaurants nationwide from Thursday, September 19, 2019. Pizza Hut has partnered with Cheez-It to launch a new item to its menu - the Stuffed Cheez-It Pizza. The pizza chain, a subsidiary of Yum! Brands, said that the new item combines Pizza Hut pizza and the Cheez-It cheese snack. Stuffed Cheez-It Pizza will be available on Pizza Hut menus nationwide for a limited-time. Pizza Hut is the official pizza sponsor of the NFL and NCAA.
Follow RTT