Recently, the World Health Organization (WHO) has pointed out that the absence of appropriate regulatory frameworks for biosimilars may have led to the approval of follow-on biologicals that cannot be considered biosimilars according to current WHO biosimilar guidelines, which were coined ‘non-innovator biologicals’ by WHO. In order to investigate the existence of ‘non-innovator biologicals’ in global markets, more understanding of the structure of the market and the manufacturers that are active in this field is needed.
In light of the existing knowledge gaps, a recently published study  has created a cross-sectional overview of manufacturers of follow-on biologicals for 18 active substances. The study looked at 15 countries from different regions of the world, such as Asia (China, India, Indonesia, Malaysia and South Korea), Latin America (Argentina, Brazil, Chile and Colombia), Africa (Tanzania and South Africa) as well as countries from the Middle East region and others (Iran, Russia, Saudi Arabia and Turkey). In addition, the study included five major biosimilar markets: the EU (including UK), USA, Canada, Australia and Japan. The five major biosimilar markets/countries have long established biosimilar frameworks and therefore any follow-on biologicals approved in any of these markets products can be considered biosimilars approved in line with WHO biosimilar guidance.
The study identified a total of 304 unique follow-on biologicals from different manufacturers for the 18 active substances that were analysed. Only 67 of these 304 ‘unique’ products are approved as biosimilar in any of the five major biosimilar markets and are therefore considered biosimilars. Although it is unclear to what extent the remaining 237 follow-on biologicals followed regulatory pathways in line with WHO biosimilar guidance, the study found a number of interesting insights. The majority of these 237 follow-on biologicals are manufactured in India or China. Moreover, these products often relate to locally manufactured follow-on biologicals approved only in the respective market where they are manufactured.
This study also found that some manufacturers, in particular from India and Argentina, supply their products to other low- and middle-income countries from different regions of the world that were included in this study. This study also found that 38 follow-on biologicals have been approved in various low- and middle-income countries before the first biosimilar approval (Omnitrope®) in the EU in April of 2006. Some of these follow-on biologicals later failed to gain biosimilar approval in major biosimilar markets because of concerns about ‘biosimilarity’ with the reference product. This could potentially indicate the existence of so-called non-innovator biologicals in global markets.
Nonetheless, this study also found a positive trend regarding biosimilar approvals; about one-third of all global approvals of follow-on biologicals since 2015 are approved as biosimilar in any of the major biosimilar markets. This could indicate that more biosimilar frameworks aligned with WHO guidance are implemented globally.
This study hopes to facilitate global discussions to create more transparency and clarity about manufacturers and their products, and at the same time facilitate better coordination among global regulatory authorities and ensure worldwide access to safe and effective biosimilars approved in line with WHO biosimilar standards.
Conflict of interest
The work of this study project  was funded by the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA).
For full details of the authors’ conflict of interest, see the research paper .
Abstracted by Mr Kevin Klein, Exon Consultancy, Amsterdam, The Netherlands.
Readers interested to learn more about the status of biosimilars approved in 16 countries are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:
Biosimilars – status in July 2020 in 16 countries
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1. Klein K, Gencoglu M, Heisterberg J, et al. The global landscape of manufacturers of follow-on biologics: an overview of five major biosimilar markets and 15 countries. BioDrugs. 2023;37:235-45.
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