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