Skip to main content

Cimerli FDA Approval History

Last updated by Judith Stewart, BPharm on Aug 3, 2022.

FDA Approved: Yes (First approved August 2, 2022)
Brand name: Cimerli
Generic name: ranibizumab-eqrn
Dosage form: Intravitreal Injection
Company: Coherus BioSciences, Inc.
Treatment for: Macular Degeneration, Macular Edema, Diabetic Macular Edema, Diabetic Retinopathy, Myopic Choroidal Neovascularization

Cimerli (ranibizumab-eqrn) is a vascular endothelial growth factor (VEGF) inhibitor, interchangeable biosimilar to Lucentis indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), diabetic retinopathy (DR), and myopic choroidal neovascularization (mCNV).

  • Cimerli is the second approved biosimilar to Lucentis (ranibizumab) after Byooviz (ranibizumab-nuna), but is the first interchangeable biosimilar. Interchangeable biosimilar means it may be substituted for the reference product at the pharmacy without consulting the prescriber, subject to state law.
  • The FDA approval of Cimerli was based on a review of safety and efficacy data that demonstrated Cimerli is biosimilar to Lucentis.
  • Cimerli is indicated for the same five indications as Lucentis.
  • Cimerli is administered via intravitreal injection once a month, approximately every 28 days.
  • Warnings and precautions associated with Cimerli include endophthalmitis and retinal detachments; increases in intraocular pressure (IOP); and potential risk of arterial thromboembolic events.
  • Common adverse reactions include conjunctival hemorrhage, eye pain, vitreous floaters, and increased IOP.


Development timeline for Cimerli

Aug  2, 2022Approval FDA Approves Cimerli (ranibizumab-eqrn), an Interchangeable Biosimilar to Lucentis

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.