Biosimilar pipelines for South Korean firms: Celltrion and Samsung Bioepis

Biosimilars/General | Posted 04/06/2021 post-comment0 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.

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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. 

Related article
Biosimilar pipelines: Chong Kun Dang, DM Bio and HK inno.N

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.

Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.

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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