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Approved biosimilars for South Korean firms: Celltrion and Samsung Bioepis

Biosimilars/General | Posted 21/05/2021 0 Post your comment

Korean companies, such as Celltrion Healthcare (Celltrion) and Samsung Bioepis (Samsung and Biogen’s joint venture), are becoming more and more important both in the country and worldwide when it comes to developing biosimilars.

Increasing investment in the biotech sector from the South Korea’s government and private pharmaceutical companies is encouraging growth in the sector. In 2019, Celltrion said that it would spend about US$33.6 billion on its pharmaceuticals business over the next decade, which would include investments in its biologicals operations [1]. While Samsung pledged in 2018 to invest US$22 billion across business lines over the next few years to propel future growth including biopharmaceuticals, artificial intelligence and auto electronics [1].

Celltrion is leading the way for Korean biosimilars makers. It was the first company in the world to receive approval for an infliximab biosimilar, Remsima, which was approved in South Korea in 2012 [2] and in Europe in 2013 [3]. Since then, the company has launched a subcutaneous (SC) formulation of its infliximab biosimilar, Remsima SC [4], as well as biosimilars of rituximab and trastuzumab, see Table 1.

Samsung Bioepis is expanding its biosimilar presence in Europe, with five of its products already approved in the region [3], as well as around the world, see Table 1.

Table 1: Approved biosimilars for South Korean firms: Celltrion and Samsung Bioepis

Company	Product name	Active substance	Therapeutic area	Stage of development
Celltrion	Herzuma (CT‑P6)	trastuzumab	Early breast cancer Metastatic breast cancer Metastatic gastric cancer	Approved in Europe, USA, Australia, Canada, Japan and South Korea [5].
	Remsima (Inflectra) /Remsima SC (CT‑P13)	infliximab	Ankylosing spondylitis Crohn’s disease Psoriatic arthritis Psoriasis Rheumatoid arthritis Ulcerative colitis	IV version approved in Europe, USA, Australia, Brazil, Canada, Colombia, Japan, South Korea and Venezuela. Approved in Russia as Flammegis. Received approval to start clinical trials in China. SC version approved in Europe [6].
	Truxima (CT‑P10)	rituximab	Chronic lymphocytic leukaemia Granulomatosis with polyangiitis Microscopic polyangiitis Non-Hodgkin’s Lymphoma Rheumatoid arthritis	Approved in Europe, Australia, South Korea. WHO announced prequalification in May 2020 [7].
Samsung Bioepis	Aybintio/Onbevzi (SB8)	bevacizumab	Breast neoplasms Colorectal neoplasms Fallopian tube neoplasms Non-small-cell lung carcinoma Ovarian neoplasms Peritoneal neoplasms Renal cell carcinoma Uterine cervical neoplasms	Approved in Europe and South Korea [8].
	Benepali/Brenzys/ Eticovo/Etolace (SB4)	etanercept	Axial spondyloarthritis Psoriatic arthritis Plaque psoriasis Rheumatoid arthritis	Approved in Europe, USA, Australia, Canada and South Korea [9].
	Flixabli/Remaloce/ Renflexis (SB2)	infliximab	Ankylosing spondylitis Crohn’s disease Psoriatic arthritis Psoriasis Rheumatoid arthritis Ulcerative colitis	Approved in Europe, USA, Australia, Canada and South Korea [6].
	Imraldi/Hadlima/ Adalloce (SB5)	adalimumab	Ankylosing spondylitis Arthritis Crohn’s Disease Hidradenitis suppurativa Psoriatic arthritis, Psoriasis Rheumatoid arthritis Ulcerative colitis Uveitis	Approved in Europe, USA, Australia, Canada and South Korea [10].
	Ontruzant/ Samfenet (SB3)	trastuzumab	Early breast cancer Metastatic breast cancer Metastatic gastric cancer	Approved in Europe, USA, Australia, Brazil and South Korea [5].
FDA; US Food and Drug Administration; IV: intravenous; SC: subcutaneous; USA: United States of America.

The two companies have been engaged in fierce competition in Europe to gain market share for their trastuzumab biosimilars. Samsung Bioepis launched Ontruzant in Europe in March 2018 – two months earlier than Celltrion’s Herzuma. Despite getting an early start, neither appears to have so far gained a dominant share in the market. Celltrion does appear to be winning, however, in Japan. The company announced in March 2021 that Herzuma had reached a market share of 44% in the company in 2020.

Celltrion also has nine biosimilars in its pipeline at various stages of development and Samsung Bioepis has five [11].

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. South Korea increases investment in biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 May 21]. Available from: www.gabionline.net/Biosimilars/General/South-Korea-increases-investment-in-biologicals
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in South Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 May 21]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-South-Korea
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 May 21]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
4. GaBI Online - Generics and Biosimilars Initiative. Celltrion launches infliximab biosimilar Remsima SC in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 May 21]. Available from: www.gabionline.net/Biosimilars/News/Celltrion-launches-infliximab-biosimilar-Remsima-SC-in-Europe
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of trastuzumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 May 21]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-trastuzumab
6. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of infliximab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 May 21]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-infliximab
7. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of rituximab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 May 21]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-rituximab
8. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of bevacizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 May 21]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-bevacizumab
9. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of etanercept [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 May 21]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-etanercept
10. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of adalimumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 May 21]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-adalimumab
11. GaBI Online - Generics and Biosimilars Initiative. Biosimilar pipelines for South Korean firms: Celltrion and Samsung Bioepis [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 May 21]. Available from: www.gabionline.net/Biosimilars/General/Biosimilar-pipelines-for-South-Korean-firms-Celltrion-and-Samsung-Bioepis

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Source: Celltrion, KoreaBiomedReview, Samsung Bioepis, The Korea Herald