The prevalence of chronic diseases like diabetes, cancer and rheumatoid arthritis have been increasing globally, resulting in an ever-growing need for biologicals that are affordable and accessible in the Asia Pacific countries (APAC). Biosimilars are ‘similar’ versions of approved and authorized biological medicines that are already on the market. They typically sell at discounts ranging from 20% to 35% when compared to the reference product [1]. It is expected that introduction of biosimilars into the global markets will erode the total sales of biologicals by as much as 54% through 2022 [2]. Various regulatory bodies such as the European Medicines Agency (EMA), the US Food and Drug Administration (FDA) and the World Health Organization (WHO) actively regulate development and commercialization of biosimilars.
APAC is witnessing a boom of biosimilars and many biologicals’ companies are either already established or are in the process of establishing their manufacturing facilities in order to provide affordable products to Asian patients [3]. South Korea, which is considered to be a leading location for biosimilars manufacturing, is already ahead of Europe in this area. It is estimated that 30% of the total biosimilars market today belongs to developing markets and that, in particular, the Asia-Pacific region (APAR), and this market is growing at a rate of 30%. With 60% of the global population based in Asia, there are more biosimilars in development in the APAR compared to any other geographic region [4, 5].
Many APACs are expediting the development of biosimilars [6]. For example, South Korea is at the forefront of an expanding biosimilars market because the South Korean government has been actively providing capital, generous tax breaks and regulatory guidance to local biosimilars companies. In 2019, the South Korean government announced an investment of approximately US$2.6 billion into biotech-related R & D and commercialization in order to support the development of new drugs and devices [7]. There is a compulsory National Health Insurance (NHI) with universal coverage to cover the entire population of South Korea. Also, the South Korean government had introduced a consulting programme called ‘Columbus’, which aims to help local biologicals companies understand the regulatory process for biosimilars approval in South Korea and abroad [8].
In Japan, the uptake of biosimilars is also burgeoning, making Japan an attractive market for biosimilars sponsors. The first Japanese biosimilar (Filgrastim BS) approved in 2012 achieved a volume share of approximately 45% in two years. On the other hand, Insulin glargine BS achieved an approximately 9% volume share in the two months after its launch in 2016 [2]. In 2016, the Japan Biosimilar Association (JBSA) was established to address biosimilar penetration challenges like encouraging prescribers/pharmacy/hospitals to use biosimilars and removing the high cost medical care benefit system [9]. In addition, the Japanese government has launched the Honebuto policy to develop biosimilars and promote NHI schemes, high-cost medical care benefit programmes and other reimbursements which will improve the use of biologicals and which in turn should increase the market size of biosimilars [8].
China and India are also considered to be leading nations in the development and commercialization of biosimilars. While this class of products have been in these markets for decades, the requisite guidelines and standards were implemented only in the last five to six years [10, 11].
The Chinese government offers a number of initiatives to facilitate development and adoption of biosimilars. These include developing multinational clinical centres, sharing clinical data globally, accelerating the approval process of special medicine, and enhancing the protection of clinical data. In addition, the Marketing Authorisation Holder (MAH) plan has been launched to allow license holders of a drug to sell in China using a contract manufacturer [12].
The Indian government has also been actively promoting biological drug development under the ‘Make in India’ campaign. To enhance research and development of biopharmaceutical products, the Department of Biotechnology (DBT), in collaboration with the World Bank, initiated an industry-academia collaborative mission ‘National Bio-Pharma Mission’ with a budget of US$250 million to be implemented by the Biotechnology Industry Research Assistance Council (BIRAC). There are more than 2,700 biotechnology start-up firms, 600 biotechnology companies and 100 biotechnology incubators in India [6].
Other Asian countries including Singapore, Malaysia, Thailand, Indonesia and Taiwan have also established biosimilars regulatory pathways and this has resulted in an increasing number of biosimilars appearing in their markets and thus, benefiting the patients. Also, the concept of universal health care is rising in ‘pharmerging’ countries (like Thailand and Indonesia) to provide better access to drugs through subsidies and reimbursement schemes. According to the Market Data Forecast, the size of the biosimilars market in the Asia Pacific was worth US$1.26 million in 2019 and is estimated to be growing at a compound annual growth rate (CAGR) of 31.6% to reach US$4.99 million by 2024 [6]. The foundation has been laid for the biosimilar industry in APAC. The role of government continues to be crucial for the success of the biosimilar industry in a given jurisdiction.
Conflict of interest
The authors of the research paper [6] declared that there was no conflict of interest.
Abstracted by Anurag S Rathore, Department of Chemical Engineering, Indian Institute of Technology, Delhi, New Delhi, India.
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