On 22 January 2024, it was announced that in the US, Sandoz will acquire ranibizumab biosimilar Cimerli (ranibizumab) from Coherus BioSciences.
The US$170 million upfront cash purchase includes a biologicals license application, product inventory, ophthalmology sales and field reimbursement talent, and access to proprietary commercial software.
Their press release stated, ‘Sandoz looks forward to providing even more treatment options for US patients with vision impairment and loss. The agreement to acquire the Cimerli business from Coherus allows us to build a more robust ophthalmic platform that would support future product launches.’
Ranibizumab is a monoclonal antibody drug indicated for the treatment of various retinal conditions including wet age-related macular degeneration (AMD), macular oedema, degenerative myopia and diabetes complications; all conditions of the eye causing vision loss [1].
Lucentis is the originator product developed by Roche/Genentech and is a blockbuster drug with global revenue of around US$3.4 billion in 2021, with just over 40% of sales in the US [2]. However, in Roche’s 2023 half-yearly report, the interim sales of Lucentis were US$328 million (2022: US$606 million), reflecting a decline of 46% due to the ongoing switch of patients from Lucentis to Vabysmo, as well as competitive pressure from the launch of ranibizumab biosimilars.
The biosimilar, Cimerli (also known as Ranivisio, Ongavia, FYB201 and CHS-201), was developed by Swiss biotechnology company Bioeq, a joint venture between Poland-based Polpharma Biologics and Germany-based Formycon [3]. In 2019, US-based Coherus acquired the rights to commercialize Bioeq’s ranibizumab biosimilar in the US [4]. Cimerli solution for injection 0.3 mg (6 mg/mL) and 0.5 mg (10 mg/mL) was approved by US Food and Drug Administration in 2022.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of ranibizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Feb 9]. Available from:
www.gabionline.net/biosimilars/general/Biosimilars-of-ranibizumab
2. GaBI Online - Generics and Biosimilars Initiative. Byooviz: first ophthalmology biosimilar launches in US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Feb 9]. Available from:
www.gabionline.net/biosimilars/news/byooviz-first-ophthalmology-biosimilar-launches-in-us
3. GaBI Online - Generics and Biosimilars Initiative. FDA approves first interchangeable ranibizumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Feb 9]. Available from:
www.gabionline.net/biosimilars/news/fda-approves-first-interchangeable-ranibizumab-biosimilar
4. GaBI Online - Generics and Biosimilars Initiative. Teva signs deal with Bioeq for ranibizumab biosimilar FYB201 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Feb 9]. Available from:
www.gabionline.net/pharma-news/teva-signs-deal-with-bioeq-for-ranibizumab-biosimilar-fyb201
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