Copies of Biological Medicines: Similar But Not the Same?

The article of Klein et al. [4] in this issue of BioDrugs describe a cross-sectional overview of copy biologicals approved in 15 countries from different regions of the world. The authors retrieved data from different public sources. The authors focused on active substances for which there are licensed copies of originator products, WHO-type biosimilars, or non-biosimilar products. They found 304 copy biologics from different manufacturers for the 18 active substances included in this study. Of these 304 copy biologicals, 67 (22%) are approved as a biosimilar in at least one of the five major biosimilar markets used as a reference (European Union, USA, Canada, Australia, and Japan).

According to Klein et al. [4], some of the remaining 237 (78%) follow-on biologics could not have been developed according to the WHO guideline because they were either licensed before publication of the guideline or before the licensing of the first biosimilar in the European Union in 2006 or even before the licensing of the originator product. In addition, some of these products failed to be licensed in the “highly regulated” ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) countries adhering to the WHO-type biosimilar development. Finally, some products were licensed via the generic pathway designed for chemical drugs. The number of non-biosimilar copy products is an underestimate in studies of both the WHO and Klein et al. because of limited sets of countries that were investigated and limitations of the methodologies [3, 4]. Klein et al. [4] found that of the 304 copy biologicals, the majority are manufactured in India (78 [25.7%]) and China (62 [20.4%]), followed by Russia (25 [8.2%]), South Korea (25 [8.2%]), Iran (23 [7.6%]), and Argentina (20 [6.6%]). Furthermore, only seven follow-on biologics from India and one from China are approved as biosimilars in any of the five major biosimilar markets. The WHO report also mentioned Ukraine as a developer of non-biosimilar copy biologicals [3]. Most non-biosimilar copy biologicals that have not been licensed in the five main markets are manufactured and used in the same country. Only 20% are used in at least two other countries whereas only a few have a wider market distribution [4].

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