U.S. License Holder:
Genentech
Date of License:
June-30-2006
Last Update:
May-15-2022
FDA-Approved Indications
LUCENTIS (ranibizumab), a vascular endothelial growth factor (VEGF) inhibitor, is indicated for the treatment of patients with:
Neovascular (Wet) Age-Related Macular Degeneration (AMD);
Macular Edema Following Retinal Vein Occlusion (RVO);
Diabetic Macular Edema (DME);
Diabetic Retinopathy (DR);
Myopic Choroidal Neovascularization (mCNV).
aBLA / 505(b)(2) Activity
aBLA / 505(b)(2) Approved by FDA
Byooviz (Samsung Bioepis / Biogen) (September-2021)
aBLA / 505(b)(2) Accepted by FDA
FYB201 (also known as CHS-201): Formycon / Bioeq / Coherus (December-2019, withdrawn February-2020, Resubmitted August-2021)
Approved Foreign Follow-On Biologics / Biosimilars
Biosimilars Approved In Canada
Byooviz (Samsung Bioepis / Biogen) (March-2022)
Biosimilars Approved In The E.U.
Byooviz (Samsung Bioepis / Biogen) (August-2021)
Biosimilars Approved In South Korea
Amelivu (Samsung Bioepis) (May-2022)