Sandoz has concluded the acquisition of the US biosimilar CIMERLI from Coherus BioSciences, marking a significant expansion of its ophthalmology and biosimilar expertise in the US market.
The transaction, valued at $170m in upfront cash, encompasses the full CIMERLI business, including a biologics licence application, product inventory, specialised commercial software, ophthalmology sales and field reimbursement talent.
CIMERLI, a US Food and Drug Administration (FDA)-approved biosimilar to the reference product LUCENTIS, is indicated for the treatment of retinal diseases. These can lead to significant vision loss and are among the top ten causes of disability in the country.
The biosimilar, which is an anti–vascular endothelial growth factor therapy, has been shown to help patients with retinal diseases maintain or improve their vision.
The acquisition was agreed by the companies in January 2023.
CIMERLI comes in 6mg/mL and 10mg/mL concentrations and is designed for injection.
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It addresses retinal ailments such as diabetic macular oedema, diabetic retinopathy macular oedema after retinal vein occlusion, myopic choroidal neovascularisation, and neovascular (wet) age-related macular degeneration.
Approved by the FDA in August 2022 and launched two months later, CIMERLI met the regulator’s standards of biosimilarities, including safety, efficacy and quality.
It is the first and only FDA-approved biosimilar interchangeable with LUCENTIS for all its indications.
Sandoz North America president Keren Haruvi stated: “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.”
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