HK inno.N–mAbxience partnership in Korea and Coherus advances in the US

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HK inno.N–mAbxience partnership in Korea and Coherus advances in the US

INICIO/Noticias Farmacéuticas | Posted 17/02/2023 0 Post your comment

In early 2023, it was announced that South Korea’s HK inno.N signed an exclusive license agreement with Spain's mAbxience to bring a denosumab biosimilar to market in South Korea. In addition, in the US, Coherus BioSciences is to acquire exclusive commercial rights to Formycon’s under-development Eylea (aflibercept) biosimilar.

mAbxience denosumab biosimilar in Korea
Denosumab is a humanized monoclonal antibody that is an inhibitor of the receptor activator of nuclear factor kappa-B ligand (RANKL), which works by preventing the development of osteoclasts which are cells that break down bone. It is used for the treatment of osteoporosis, treatment-induced bone loss, metastases to bone and giant cell tumour of bone [1]. The originator product is Amgen’s Prolia/Xgeva (denosumab).

Under the terms of the agreement, HK inno.N will exclusively market two types of denosumab biosimilars (60 mg and 120 mg) developed by mAbxience.

Coherus BioSciences rites to aflibercept biosimilar
Aflibercept is a vascular endothelial growth factor (VEGF) inhibitor for the treatment of certain eye diseases. It is indicated for the treatment of neovascular (wet) age-related macular degeneration, macular oedema following retinal vein occlusion, diabetic macular oedema and diabetic retinopathy in patients with diabetic macular oedema [2]. The originator was developed by Regeneron.

Coherus BioSciences executed a binding term sheet with Klinge Biopharma for the exclusive commercialization rights to FYB203, Formycon’s aflibercept biosimilar candidate. This is currently being evaluated in a phase III clinical trial and results are expected in February/March 2023. Coherus hopes to file a Biologics License Application with the US Food and Drug Administration later in 2023. If approved, this will join Cimerli (ranibizumab, a Lucentis biosimilar) as an ophthalmic biosimilar marketed by Coherus in the US [3].

Pegfilgrastim biosimilar Udenyca demonstrated similar immunogenicity to Neulasta

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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of denosumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Feb 17]. Available from:
www.gabionline.net/biosimilars/general/Biosimilars-of-denosumab
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of aflibercep [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Feb 17]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-aflibercept
3. GaBI Online - Generics and Biosimilars Initiative. Progress for Lucentis (ranibizumab) biosimilars in Europe and the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Feb 17]. Available from: www.gabionline.net/biosimilars/news/progress-for-lucentis-ranibizumab-biosimilars-in-europe-and-the-us

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