Biosimilars – status in July 2020 in 16 countries

Abstract

The World Health Organization has provided specific guidance for biosimilar products to assist regulators, manufacturers and other professionals involved in the development and evaluation of these products. The development and approval of biosimilars are important for health care, as they allow the marketing of safe, efficacious and affordable biological products. Since the first biosimilars were approved in the EU in 2006, a series of biosimilars have been approved in many countries/geographical regions. This manuscript provides the figures on the status of approved biosimilars in 16 countries based on the information from regulatory experts and from publicly available data. It is clear that increasing numbers of biosimilars are now available in many countries and provide more options for treatments. It is expected that adoption of biosimilars will allow affordable health care and greater patient access to important medicinal products. It will also contribute to the overall WHO goal recognized by the World Health Assembly in 2014 by adopting a resolution on access to biotherapeutic products including biosimilars and on ensuring their quality, safety and efficacy.

The Global Landscape of Manufacturers of Follow-on Biologics: An Overview of Five Major Biosimilar Markets and 15 Countries

“…As Table S1 of the ESM shows, this mainly concerns 'older' generation biologics, such as locally produced epoetin alfa, filgrastim and insulins, which have been approved before 2006 in the respective country of manufacturing. This is also supported by the findings of Kang et al, who showed that the majority of follow-on biologics that cannot be considered biosimilars (termed non-innovator biologics by the WHO) are found in the product classes of insulins, filgrastim, interferons and epoetin alfa [8,13]. This may not be surprising as, historically, these older generation biologics comprise smaller and less complex products, which are easier to replicate and may therefore be more likely to trigger generic competition by local manufacturers.…”

“…In contrast to previous studies looking into general marketing authorisation applications of biosimilars, this study adds granularity by identifying and distinguishing between different follow-on biologics [ 13 ]. In order to do so, we defined the manufacturer of the active substance as the primary unit of analysis.…”

“…In a recent survey on biosimilar related topics conducted by the WHO, it was noted that the absence of appropriate regulatory frameworks for biosimilars may have led to the approval of many follow-on biologics that do not meet WHO biosimilar standards (i.e. and should therefore not be regarded as biosimilars) [ 12 , 13 ]. The term follow-on biologics is therefore used throughout this article to describe both (i) products that are approved as biosimilars by a stringent regulatory authority, such as the EU (including the UK), USA, CA, AU and JP, and (ii) products that are not biosimilars as so defined but that are approved subsequent to originator reference products and sometimes referred to as non-innovator biologics by the WHO.…”

WHO informal consultation on revision of guidelines on evaluation of similar biotherapeutic products, virtual meeting, 30 June – 2 July 2021

“…Other important issues relate to the practice of interchangeability and the naming and labelling of biosimilars. Survey details and outcomes have been published [ [6] , [7] , [8] ].…”