Cimerli Offers a New, Interchangeable Biosimilar for Ocular Conditions

This article was originally published on Pharmacy Times^®. This version has been lightly edited.

Cimerli (ranibizumab-eqrn; Sandoz) is a recombinant humanized monoclonal antibody fragment that functions as a vascular endothelial growth factor (VEGF) inhibitor. It is an interchangeable biosimilar to ranibizumab (Lucentis; Genentech), which is a treatment option for eye and retinal vascular disorders.¹

More than 19.8 million Americans aged 40 or older have age-related macular degeneration (AMD). The prevalence of this condition increases with age, and women are more often affected than men.²

Cimerli is indicated for nAMD | Image credit: Dilshad | stock.adobe.com

Cimerli is known to be used for minimally classic/occult lesions, which are a subtype of neovascular AMD (nAMD). AMD is a less common condition of macular damage but is very serious. The most common type is dry age-related macular degeneration, in which the macula becomes thin and small, resulting in deposits forming under the retina. For nAMD, this condition occurs when new abnormal blood vessels grow underneath the retina in the eyes, which can cause leakage of blood or fluid, causing scarring of the macula. As a result of the scarring, vision loss may develop quicker.²

Some symptoms include blurred vision, usually within the center of the eye; abnormal wavy or crooked-looking straight lines; difficulty seeing fine details at close range; and decreased ability to recognize faces or read. This type of macular degeneration primarily affects patients aged 50 and older.³

A biosimilar medication like Cimerli demonstrates biological function, pharmacokinetics, pharmacodynamics, safety, immunogenicity, drug stability, and drug purity like that of Lucentis with no clinically meaningful difference. Cimerli is the first and only FDA-approved interchangeable biosimilar to Lucentis that was introduced. It received FDA approval on August 2, 2022, and became commercially available in the United States on October 3, 2022.¹

Cimerli is indicated for nAMD, macular edema after retinal vein occlusion, diabetic macular edema (DME), diabetic retinopathy, and myopic choroidal neovascularization. To qualify for interchangeability, Cimerli was shown to have low complexity, a low incidence of immunogenicity, and comparable serious adverse effects to Lucentis. It has the same formulations, amino acid sequencing, indication, and dosage strength.⁴

Cimerli binds with high affinity to the receptor’s binding domain of the active form of VEGF-A. This causes prevention of interaction between VEGF-A and its cell surface receptors, VEGF receptor 1 and VEGF receptor 2. This inhibition leads to the reduction of endothelial cell proliferation, vascular leakage, and formation of new blood vessels, resulting in the slowing of disease progression to preserve vision.⁴

Dosing of Cimerli depends on the therapeutic condition being treated and must be administered by a qualified ophthalmic health care provider under sterile conditions. For neovascular nAMD, macular edema after retinal vein occlusion, or myopic choroidal neovascularization, the recommended dosing is 0.5 mg given by intravitreal injection once every 28 days. For myopic choroidal neovascularization, there is a maximum use time of 3 months. The recommended dose for diabetic macular edema or diabetic retinopathy is 0.3 mg given by intravitreal injection every 28 days with no maximal usage duration.¹

The use of Cimerli is contraindicated in those with ocular or periocular infection or hypersensitivity to ranibizumab products. Caution should be used with patients who have a history of cardiovascular diseases. Some of the common ocular adverse effects known to appear with the use of Cimerli are conjunctival hemorrhage, eye pain, vitreous floaters, and increased intraocular pressure. Non-ocular common adverse effects include nasopharyngitis, anemia, nausea, and cough. In more serious cases, patients may experience an increase in intraocular pressure before and after injection when being treated with ranibizumab products.⁵

REFERENCES

1. Ranibizumab-eqrn [prescribing information]. Sandoz Inc; June 2024. Accessed April 24, 2025. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=4b383d74-4830-4587-95f7-c32a39268df7&type=display

2. Age-related macular degeneration. CDC. May 15, 2024. Accessed April 24, 2025. https://www.cdc.gov/vision-health-data/case-definitions/age-related-macular-degeneration-amd.html

3. Boyd K. Understanding macular degeneration. American Academy of Ophthalmology. October 1, 2024. Accessed April 24, 2025. https://www.aao.org/eye-health/diseases/amd-macular-degeneration

4. Cimerli. Accessed April 24, 2025. https://www.cimerli.com/

5. Coherus to launch Cimerli (ranibizumab-eqrn) in the United States on October 3, 2022. Accessed April 24, 2025. https://investors.coherus.com/news-releases/news-release-details/coherus-launch-cimerlitm-ranibizumab-eqrn-united-states-october