- CIMERLI*, a ranibizumab biosimilar, is interchangeable with LUCENTIS** (ranibizumab injection) for all approved indications
- Dedicated retina sales and field reimbursement team integrated into Sandoz, ensuring seamless experience for providers and patients
Sandoz, the global leader in generic and biosimilar medicines, has completed the acquisition of the US biosimilar CIMERLI* (ranibizumab-eqrn) from Coherus BioSciences, Inc, ahead of anticipated timelines. The acquisition builds on the leading Sandoz ophthalmic platform in the US and lays an even stronger foundation for future product launches.
Keren Haruvi, President Sandoz North America said: “Today we further expand the Sandoz biosimilar portfolio, while advancing our mission in the US of pioneering patient access to more affordable and much-needed medicines. With the addition of CIMERLI to our existing ophthalmology franchise, we can now offer even more treatment options for US patients with vision impairment and loss.”
CIMERLI® is indicated for the treatment of certain retinal diseases that, if left untreated, can cause vision loss, which ranks among the top 10 causes of disability in the United States.1 It is an anti-VEGF therapy within a class of biologics that helps retinal patients maintain or gain vision.2
Sandoz and Coherus entered into an agreement in January 2024 through which Sandoz agreed to acquire the full CIMERLI business for an upfront cash purchase price of USD $170 million. The transaction includes a biologics license application, product inventory, ophthalmology sales and field reimbursement talent, as well as access to proprietary commercial software.
About CIMERLI
CIMERLI* solution for injection (6 mg/mL and 10 mg/mL) is an FDA-approved biosimilar to reference product LUCENTIS** (ranibizumab injection) indicated for the treatment of multiple retinal diseases, including 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).3 CIMERLI* is an anti-VEGF therapy within a class of biologics that helps retinal patients maintain or gain vision.2 CIMERLI* was approved by the FDA in August 2022, having met FDA’s rigorous standards of biosimilarity to the reference product, including safety, efficacy and quality. Launched in October 2022, it is the first and only FDA-approved biosimilar interchangeable with LUCENTIS** for all indications.
IMPORTANT SAFETY INFORMATION & INDICATIONS
CIMERLI* (ranibizumab-eqrn) is interchangeable*** to LUCENTIS** (ranibizumab injection).
CIMERLI* (ranibizumab-eqrn), 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)
CONTRAINDICATIONS
- Ocular or periocular infections
- Hypersensitivity
WARNINGS AND PRECAUTIONS
- Endophthalmitis and retinal detachments may occur following intravitreal injections. Patients should be monitored following the injection
- Increases in intraocular pressure (IOP) have been noted both pre- and post-intravitreal injection
- There is a potential risk of arterial thromboembolic events following intravitreal use of vascular endothelial growth factor (VEGF) inhibitors
- Fatal events occurred more frequently in patients with diabetic macular edema and diabetic retinopathy at baseline, who were treated monthly with ranibizumab compared with control
ADVERSE REACTIONS
- The most common adverse reactions (reported more frequently in ranibizumab-treated subjects than control subjects) are conjunctival hemorrhage, eye pain, vitreous floaters, and increased IOP
For additional Safety Information, please see CIMERLI Full Prescribing Information available here.
To report SUSPECTED ADVERSE REACTIONS, contact Coherus BioSciences at 1-800-483-3692 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
*CIMERLI is a registered trademark of Coherus BioSciences, Inc.
**LUCENTIS is a registered trademark of Genentech USA, Inc.
***An interchangeable product (IP) is a biological product that is approved based on data demonstrating that it is highly similar to an FDA-approved reference product (RP) and that there are no clinically meaningful differences between the products; it can be expected to produce the same clinical result as the RP in any given patient; and if administered more than once to a patient, the risk in terms of safety or diminished efficacy from alternating or switching between use of the RP and IP is not greater than that from the RP without such alternation or switch. Interchangeability of CIMERLI®* has been demonstrated for the condition(s) of use, strength(s), dosage form(s) and route(s) of administration described in its Full Prescribing Information.