Drug Discovery and Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Voices
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE

FDA Approves Udenyca, Biosimilar to Neulasta

By Coherus BioSciences, Inc. | November 2, 2018

Coherus BioSciences has received FDA approval for Udenyca (pegfilgrastim-cbqv), the first pegfilgrastim biosimilar approved by both the FDA and the European Commission (EC) for patients with cancer receiving myelosuppressive chemotherapy. Udenyca is Coherus’ first drug to receive FDA or EC approval. 

“We are excited to announce that Coherus has received FDA approval for Udenyca. I want to thank the Coherus team, our strategic partners, and the U.S. Food and Drug Administration for this extraordinary achievement,” said Denny Lanfear, chairman, CEO and president of Coherus BioSciences. “The list price of Neulasta has nearly tripled since approval in 2002 and now represents a $4 billion annual cost burden in the U.S. We believe that competition is essential in controlling burdensome price increases, and Udenyca will play an important role in curbing that spend when launched. Our in-depth understanding of the market will allow us to deliver significant value to patients, payors, and providers in the U.S., including 340B hospitals, small clinics and small hospitals.”

“For a number of reasons we believe the oncology marketplace is ideal for biosimilars, and we are committed to a vigorous product launch,” said Chris Thompson, Senior Vice President of Sales. “Our oncology-focused, highly capable and fully-staffed commercial team is in place. We are confident that our U.S.-based manufacturing network has the finished goods in inventory to meet our highest expected demand for an extended period.”

The approval of Udenyca was supported by a comprehensive analytical similarity package, as well as pharmacokinetic, pharmacodynamic and immunogenicity studies, including over 600 healthy subjects.

“Udenyca’s robust clinical package includes a dedicated immunogenicity similarity study in over 300 healthy subjects,” said Barbara Finck, M.D., CMO of Coherus BioSciences. “In support of that study, and as part of our commitment to ensuring patient safety, we deployed a battery of sensitive immunogenicity assays. This effort not only supported the biosimilarity of Udenyca, but also advanced the understanding of the immunogenic response of pegfilgrastim products.”

The European Commission approved Udenyca on September 21, 2018.

About Udenyca
Udenyca (pegfilgrastim-cbqv), formerly CHS-1701, is a PEGylated growth colony-stimulating factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. Udenyca drug substance manufacturing is located in Boulder, Colorado. Pegfilgrastim is one of the largest selling oncology biologics with worldwide revenues in excess of $4.5 billion in 2017.

Udenyca is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

(Source: Coherus BioSciences, Inc.) 


Filed Under: Oncology

 

Related Articles Read More >

Labcorp widens precision oncology toolkit, aims to speed drug-trial enrollment
AP Biosciences charts course for safer CD137 bispecifics with its T-cube platform
Cellares and UW-Madison partner to automate manufacturing for novel solid tumor CAR-T
Why smaller, simpler molecular glues are gaining attention in drug discovery
“ddd
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in the drug discovery and development industry.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Drug Discovery and Development
  • MassDevice
  • DeviceTalks
  • Medtech100 Index
  • Medical Design Sourcing
  • Medical Design & Outsourcing
  • Medical Tubing + Extrusion
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Pharmaceutical Processing World

Copyright © 2025 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 and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Voices
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE