China is one of the largest pharmaceutical markets in the world; and has seen rapid growth in the biologicals industry in recent years [1], while copy biologicals are being increasingly developed and used across ASEAN nations [2].

Key driving factors that have fuelled the growth of the ASEAN and China market for copy biologicals, according to the report, include:

• the rise in the number of blockbuster drugs whose patents are expiring
• the high prevalence of chronic diseases among the ageing population across the ASEAN countries and China
• the lower cost of copy biologicals compared to originator biologicals

However, the high initial investment in R & D required is anticipated to hamper the growth of the market. Moreover, increased investment by key international players in the untapped economies of the ASEAN region and China offers lucrative opportunities for the expansion of the market in these areas.

Monoclonal antibodies (mAbs) generated the highest revenue in 2017 and are expected to maintain their dominance. This is attributed to the many uses of mAbs in the healthcare sector. In addition, mAbs are increasingly applied in the development of novel treatment options for cancer, as well as in infectious, cardiovascular and inflammatory diseases. Erythropoietin had the second highest share in the ASEAN and China market for copy biologicals in 2017 and is expected to maintain this trend. While human growth hormone is anticipated to grow at the fastest pace from 2018 to 2025.

From the ASEAN nations, Indonesia generated the highest revenue in the market for copy biologicals in 2017 and is expected to remain dominant until 2025.

*The Association of Southeast Asian Nations, or ASEAN, was established on 8 August 1967 in Bangkok, Thailand with the signing of the ASEAN Declaration (Bangkok Declaration) by the Founding Fathers of ASEAN, namely Indonesia, Malaysia, Philippines, Singapore and Thailand. Then Brunei Darussalam joined on 7 January 1984, Vietnam on 28 July 1995, Lao PDR and Myanmar on 23 July 1997 and Cambodia on 30 April 1999, making up what is today the 10 Member States of ASEAN.

Editor’s comment
It should be noted that copy biologicals approved in China or in ASEAN nations might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the European Union. The European Medicines Agency regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product.

Related articles
Regulation of copy biologicals in China

Global uptake of biosimilars

References
1. GaBI Online - Generics and Biosimilars Initiative. Strategy for biosimilars in China [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Apr 24]. Available from: www.gabionline.net/Biosimilars/Research/Strategy-for-biosimilars-in-China
2. Thorpe R, Griffiths E, Ekman N. First ASEAN educational workshop on regulation and approval of biosimilars/similar biotherapeutic products 2017 – Report. Generics and Biosimilars Initiative Journal (GaBI Journal). 2018;7(3):127-32. doi:10.5639/gabij.2018.0703.025

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