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

Coherus files BLA for Lucentis biosimilar

By Brian Buntz | October 1, 2021

Coherus BiosciencesCoherus BioSciences (NSDQ:CHRS) has announced that FDA has accepted for review the 351(k) Biologics License Application (BLA) for CHS-201, a biosimilar candidate referencing the blood vessel growth inhibitor Lucentis (ranibizumab).

Developed by Genentech, Lucentis first won FDA approval in 2006 to treat wet age-related macular degeneration. Other indications followed, including macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy and myopic choroidal neovascularization.

FDA has chosen August 2, 2022, as the Biosimilar User Fee Act action date for CHS 201.

Besides CHS-201, Coherus has a range of other biosimilars in its portfolio.

In 2019, it won FDA backing for Udenyca (pegfilgrastim-cbqv), a pegfilgrastim biosimilar used to decrease the incidence of infection. The FDA label for the drug describes its use in treating patients with non-myeloid malignancies who receive myelosuppressive anti-cancer drugs.

In addition, Coherus has a biosimilar of AbbVie’s Humira under FDA review.

Coherus also has a biosimilar candidate referencing Genentech’s Avastin that is the subject of a comparative pharmacokinetic study in healthy subjects.


Filed Under: Ophthalmology
Tagged With: Avastin, biosimilar, CHS-201, Coherus, Coherus BioSciences, FDA, Humira, Lucentis, ranibizumab, Udencya
 

About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

Related Articles Read More >

AMD
Promising phase 2 data suggests new drug could save sight in dry AMD
Structure of human eye. In side view.
Gene therapy yields 100x vision average improvement, with a few reaching 10,000x
Ozempic
JAMA study suggests link between semaglutide and eye disorder
Retina slice
Molecular photoswitches: Illuminating the future of inherited retinal disease treatment
“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