Ophthalmologic Biosimilar With Interchangeability Designation Acquired by Sandoz
In clinical trials, Cimerli met FDA standards for biosimilarity to the reference Lucentis, including safety, efficacy, and quality.
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Sandoz has reached an agreement with Coherus BioSciences, Inc. to acquire Cimerli (ranibizumab-eqrn), an interchangeable biosimilar to Lucentis (ranibizumab), for an upfront cash payment of $170 million. The acquisition includes the biologics license application, product inventory, ophthalmology sales and field reimbursement staff, and access to proprietary commercial software, according to a Sandoz press release.
“I am pleased that we can add another high-value product to the growing Sandoz biosimilar portfolio, further strengthening our existing ophthalmology franchise,” said Keren Haruvi, president Sandoz North America, in the press release. “The addition of Cimerli reinforces our commitment to biosimilars and represents a huge step towards our goal of pioneering patient access to more affordable and much-needed medicines in the US.”
Cimerli solution for injection 0.3 mg (6 mg/mL) and 0.5 mg (10 mg/mL) has the same indications as Lucentis, which has been approved for the treatment of wet age-related macular degeneration, diabetic macular edema, macular edema following retinal vein occlusion, myopic choroidal neovascularization, and diabetic retinopathy. The biologic anti-VEGF therapy was approved by the FDA in August 2022 after meeting FDA standards for biosimilarity to the reference Lucentis, including safety, efficacy, and quality. Cimerli is the first and only biosimilar approved with the interchangeable designation for Lucentis for all indications.
A biosimilar granted the interchangeability designation can be substituted for the reference product at the pharmacy level without gaining permission from a physician. Interchangeability designation allows for lower wait times for patients to obtain their medications and improves biosimilar accessibility.
Biosimilars and interchangeable biosimilars do not have any clinically meaningful differences from the branded biologic products for their approved indications in terms of safety, purity, and potency. To be granted the designation by the FDA, the manufacturer must prove the candidate is biosimilar to the reference product; that the biosimilar can be expected to produce similar clinical outcomes as the reference product; and that the risk of adverse events or reduced efficacy from alternating or switching between the biosimilar and the reference product is not greater than the risk of using the reference product without a switch.
In the press release, Sandoz said the acquisition of Cimerli will enhance the company’s ophthalmic platform and support future product launches. The sale is expected to close is the first half of 2024, subject to standard conditions and approvals.
Reference
Sandoz announces agreement to acquire CIMERLI® business from Coherus, strengthening position in US market. Sandoz. News release. January 22, 2024. Accessed January 22, 2024. https://www.sandoz.com/sandoz-announces-agreement-acquire-cimerlir-business-coherus-strengthening-position-us-market/
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