Drug Discovery and Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • R&D 100 Awards
  • Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50

FDA Approves Pfizer’s Biosimilar To Neupogen

By The U.S. Food and Drug Administration | July 23, 2018

FDA approved Pfizer’s Nivestym (filgrastim-aafi), a biosimilar to Neupogen (filgrastim). This is the second approved biosimilar to Neupogen approved in the U.S.

Nivestym is approved for the same indications as Neupogen, and can be prescribed by a health care professional for:

•       patients with cancer receiving myelosuppressive chemotherapy;

•       patients with acute myeloid leukemia receiving induction or consolidation chemotherapy;

•       patients with cancer undergoing bone marrow transplantation;

•       patients undergoing autologous peripheral blood progenitor cell collection and therapy; and

•       patients with severe chronic neutropenia.

The most common expected side effects of Nivestym are aching in the bones or muscles and redness, swelling or itching at injection site. Serious side effects may include spleen rupture; serious allergic reactions that may cause rash, shortness of breath, wheezing and/or swelling around the mouth and eyes; fast pulse and sweating; and acute respiratory distress syndrome, a lung disease that can cause shortness of breath, difficulty breathing or increase the rate of breathing.

For more information about Nivestym, see the label information. 

(Source: The U.S. Food and Drug Administration)


Filed Under: Drug Discovery

 

Related Articles Read More >

lab microscope
Accelerating R&D with FAIR data
Kallyope
Kallyope’s focus on the gut-brain axis yields a diverse portfolio
Axcella
Axcella touts positive results from Phase 2a long COVID study
artificial intelligence
Defining complexity: A framework to identify complex clinical trials and set them up for success

Need Drug Discovery news in a minute?

We Deliver!
Drug Discovery & Development Enewsletters get you caught up on all the mission critical news you need. Sign up today.
Enews Signup
Drug Discovery and Development
  • MassDevice
  • DeviceTalks
  • Medical Design & Outsourcing
  • Medical Tubing + Extrusion
  • Medtech100 Index
  • Medical Design Sourcing
  • Subscribe to our Free E-Newsletter
  • Contact Us
  • About Us
  • Advertise With Us
  • R&D World
  • Drug Delivery Business News
  • Pharmaceutical Processing World

Copyright © 2022 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Drug Discovery & Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • R&D 100 Awards
  • Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50