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Sandoz acquires CIMERLI® business from Coherus, further building biosimilar and ophthalmology leadership in US market | ||||||||||
By: GlobeNewswire - 04 Mar 2024 | Back to overview list |
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MEDIA RELEASE
Basel, March 4, 2024 – 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:
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS
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. Disclaimer References
About Sandoz
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