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].
Related articles
FDA approves first interchangeable ranibizumab biosimilar
Pegfilgrastim biosimilar Udenyca demonstrated similar immunogenicity to Neulasta
Biosimilar pipelines for South Korean firms: Chong Kun Dang, DM Bio and HK inno.N
Biosimilar pipelines for South Korean firms: LG Chem and GC Pharma
|
LATIN AMERICAN FORUM
The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish. View the latest headline article: DARS: avance el desarrollo de biosimilares en los EE. UU Browse the news in the Latin American Forum! Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.
FORO LATINOAMERICANO
Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español. Ver el último artículo de cabecera: DARS: avance el desarrollo de biosimilares en los EE. UU !Explore las noticias en el Foro Latinoamericano! Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa.
|
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
Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.
Copyright – Unless otherwise stated all contents of this website are © 2023 Pro Pharma Communications International. All Rights Reserved.
0
Post your comment