Coherus 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