South Korea is becoming a more and more important spot on the map when it comes to biosimilars. Although Celltrion Healthcare (Celltrion) and Samsung Bioepis (Samsung and Biogen’s joint venture) are leading the way in Korea and worldwide, other Korean companies, such as Chong Kun Dang Pharmaceutical (Chong Kun Dang), DM Bio (joint venture between Dong-A ST and Meiji Holdings) and HK inno.N (previously CJ Healthcare), are also expanding their biosimilar pipelines.
Biosimilar pipelines for South Korean firms: Chong Kun Dang, DM Bio and HK inno.N
Biosimilars/General
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Posted 31/05/2021
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Chong Kun Dang has three biosimilars in its pipeline at various stages of development, DM Bio also has three and HK inno.N has one, see Table 1.
Table 1: Biosimilar pipelines for South Korean firms: Chong Kun Dang, Dong‑A ST and HK inno.N |
Company | Product name | Active substance | Therapeutic area | Stage of development |
Chong Kun Dang | CKD-11101 | darbepoetin alfa | Anaemia | Approved in Japan [1] |
CKD-12101 | pegfilgrastim | Neutropenia | Preclinical | |
CKD-701 | ranibizumab |
Degenerative myopia Diabetes complications Macular oedema (Wet) AMD |
Phase III | |
DM Bio | DA‑3880 | darbepoetin alfa | Anaemia | Approved in Japan [1] |
DMB 3111 | trastuzumab |
Early breast cancer Metastatic breast cancer Metastatic gastric cancer |
Phase I trial completed in Japan. DM Bio licensed development and sales rights in Europe and Russia to Gedeon Richter, a Hungarian company [2] | |
DMB 3113 | adalimumab |
Ankylosing spondylitis Crohn’s disease Juvenile rheumatoid arthritis Psoriasis Psoriatic arthritis Rheumatoid arthritis Ulcerative colitis |
Phase I trial started in Japan [3] | |
HK inno.N (formerly CJ Healthcare) | CJ-40001 | darbepoetin alfa | Anaemia | Phase III |
AMD: age-related macular degeneration; PMDA: Pharmaceuticals and Medical Devices Agency. |
Chong Kun Dang is leading the way in this group of companies, having obtained approval for its darbepoetin alfa biosimilar (CKD-11101) in Japan in December 2018 [4] and having a ranibizumab biosimilar in Phase III. While DM Bio, which is a joint venture between Dong-A ST and Meiji Holdings, is hot on its tail, having obtained Japanese approval in September 2019, licensing the drug to Sanwa Kagaku Kenkyusyo [4] and having trastuzumab and adalimumab biosimilars in Phase I.
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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. Biosimilars of darbepoetin alfa [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 May 31]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-darbepoetin-alfa
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of trastuzumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 May 31]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-trastuzumab
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of adalimumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 May 31]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-adalimumab
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Japan [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 May 31]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Japan
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