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Biosimilar pipelines for South Korean firms: Celltrion and Samsung Bioepis

Biosimilars/General | Posted 04/06/2021 0 Post your comment

Biosimilars are becoming more important around the world and Korean companies, such as Celltrion Healthcare (Celltrion) and Samsung Bioepis (Samsung and Biogen’s joint venture), are fast becoming major players both in Korea but also worldwide.

The two companies already have nine biosimilars approved in Europe and around the world: three for Celltrion and six for Samsung Bioepis [1]. They have also invested heavily in the sector [2] enabling them to have an impressive pipeline of new biosimilars on the way.

Celltrion has nine biosimilars in its pipeline at various stages of development and Samsung Bioepis has five, see Table 1.

Table 1: Biosimilar pipelines for South Korean firms: Celltrion and Samsung Bioepis
Company	Product name	Active substance	Therapeutic area	Stage of development
Celltrion	CT-P16	bevacizumab	Metastatic breast cancer Metastatic colorectal cancer	Phase III
	CT-P17	adalimumab	Psoriasis Psoriatic arthritis Juvenile idiopathic arthritis Rheumatoid arthritis Ulcerative colitis	Phase III
	CT-P42	aflibercept	(wet) AMD Macular oedema Diabetic macular oedema Diabetic retinopathy	Phase III
	CT-P43	ustekinumab	Crohn’s disease Psoriasis Psoriatic arthritis	Phase III
	CT-P39	omalizumab	Asthma Urticaria	Phase I-III
	CT-P41	denosumab	Osteoporosis	Phase I
	CT-P05	etanercept	Ankylosing spondylitis Juvenile rheumatoid arthritis Psoriasis Psoriatic arthritis Rheumatoid arthritis	In pipeline
	CT-P14	palivizumab	RSV infections	In pipeline
	CT-P15	cetuximab	Metastatic colorectal cancer Metastatic NSCLC Head and neck cancer	In pipeline
Samsung Bioepis	SB11	ranibizumab	Wet AMD Macular oedema Degenerative myopia Diabetes complications	Submitted to EMA and FDA for approval in October and November 2020, respectively [3]
	SB12	eculizumab	Atypical haemolytic uremic syndrome	Phase III
	SB15	aflibercept	(Wet) AMD Macular oedema Diabetic macular oedema Diabetic retinopathy	Phase III
	SB16	denosumab	Bone resorption Osteoporosis	Phase III
	SB17	ustekinumab	Crohn’s disease Psoriatic arthritis Psoriasis	Phase I
AMD: age-related macular degeneration; NSCLC: non-small cell lung cancer; RSV: respiratory syncytial virus.

However, Celltrion and Samsung Bioepis are not the only South Korean firms with biosimilars either approved or in the pipeline. Chong Kun Dang, Dong-A ST, CJ Healthcare, LG Chem and Green Cross are also South Korean companies that are making headway in the biosimilars sector.

LATIN AMERICAN FORUM – Coming soon!

To further enhance the objectives of GaBI in sharing information and knowledge that ensure policies supportive of safe biosimilars use, we are pleased to announce that we will be launching a new section on GaBI Online and GaBI Journal, the ‘Latin American Forum’ (in Spanish) featuring the latest news and updates on research and developments in generic and biosimilar medicines in Latin America.

LATIN AMERICAN FORUM – Próximamente!

Para fomentar los objetivos de GaBI sobre la difusión de información y conocimiento sobre las políticas de apoyo que garantizan el uso seguro de medicamentos biosimilares, nos complace anunciar el lanzamiento de una nueva sección en GaBI Online y GaBI Journal, el ‘Latin American Forum’ (en español), que presentará las últimas noticias y actualizaciones en investigación y desarrollo sobre medicamentos genéricos y biosimilares en Latinoamérica.

Regístrese para recibir el boletín informativo GaBI Latin American Forum. Informe a colegas y amigos sobre esta nueva iniciativa.

References
1. GaBI Online - Generics and Biosimilars Initiative. Approved biosimilars for South Korean firms: Celltrion and Samsung Bioepis [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jun 4]. Available from: www.gabionline.net/Biosimilars/General/Approved-biosimilars-for-South-Korean-firms-Celltrion-and-Samsung-Bioepis
2. GaBI Online - Generics and Biosimilars Initiative. South Korea increases investment in biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jun 4]. Available from: www.gabionline.net/Biosimilars/General/South-Korea-increases-investment-in-biologicals
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of ranibizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jun 4]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-ranibizumab

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