Continue to Site

Drug Discovery and Development

Coherus files BLA for Lucentis biosimilar

By |

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: , , , , , , , , ,
 

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.

Tell Us What You Think!

Related Articles Read More >

Search Drug Discovery & Development