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Biocure developing five candidate biosimilars Posted 10/04/2020

South Korea’s pharmaceutical industry has fast been expanding as a world player. According to the Korea Health Industry Development Institute, the Korean pharmaceutical industry in 2018 represented 1.8% of the world market, i.e. the 13th largest in the world.

Some of this growth has been attributed to the Korean Government’s decision in 2009 in which it identified ‘biopharmaceutical and medical equipment‘ as one of the future engines for economic growth [1]. In fact, in the very same year the country’s regulatory agency, the Ministry of Food and Drug Safety (MFDS), formerly the Korean Food and Drug Administration, published an overarching guideline for biosimilars, based on the European, Japanese and World Health Organization (WHO) guidelines [2]. To date, the country has approved 12 biosimilars [3].

As far as world players are concerned, some of the major developers of biosimilars are headquartered in South Korea. These include Celltrion and Samsung Biologics, as well as Chong Kun Dang Pharmaceutical, Daewoong Pharma, GC Pharma and LG Chem.

Now there is a new kid on the block. South Korea-based Biocure, which was only established in 2005, is developing five potential biosimilars.

The company says that it is currently carrying out preclinical trials for five major biosimilars in South Korea. These include candidate biosimilars for interferon beta 1b, pegfilgrastim and ranibizumab, as well as chimeric antigen receptor T cell (CAR-T cell) therapy.

Interferon beta 1b is used for treating relapsing forms of multiple sclerosis (MS) Filgrastim is used to treat neutropenia, a lack of certain white blood cells caused by bone marrow transplants, chemotherapy and other conditions. Ranibizumab is used for treating macular degeneration. It is also used to treat a type of eye problem known as macular oedema, as well as certain eye problems caused by diabetes.

Biocure expects to be able to commercialize its CAR-T cell therapy biosimilar in 2020. While for interferon beta 1a and ranibizumab commercialization is planned in 2021 and for pegfilgrastim in 2022.

The company is also developing a foot and mouth disease vaccine and a hair growth product.

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References
1. GaBI Online - Generics and Biosimilars Initiative. Korean biopharma gets support for biosimilars/biobetters [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Apr 10]. Available from: www.gabionline.net/Biosimilars/News/Korean-biopharma-gets-support-for-biosimilars-biobetters
2. GaBI Online - Generics and Biosimilars Initiative. South Korean guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Apr 10]. Available from: www.gabionline.net/Guidelines/South-Korean-guidelines-for-biosimilars
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in South Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Apr 10]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-South-Korea

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Source: Biocure, KHIDI

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