Biosimilars are recognised around the world as safe and effective medicines. The WHO has also released guidelines, based on those of the EU, as well as other regulated markets, such as Australia, Canada and Japan. These aim to assist less regulated markets with approval of biosimilars.

However, regulations for the approval of biosimilars remain country/region-specific. The main issue is that each region requires a reference product which has already been approved in that region. Therefore, for example, in the EU, biosimilar manufacturers are required to compare their product to a reference product approved by the EMA in Europe. Likewise for the US, a FDA approved reference product would be required.

This thus requires duplication of the clinical development in each region, which vastly increases the costs entailed to get a biosimilar to market. This is also the case even when the reference product is made at a single facility for worldwide use.

The authors suggest that data showing that region-specific reference products are indistinguishable and should be acceptable to enable a global dossier for a potential biosimilar to be produced.

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Reference

1. McCamish M, Woollett G. Worldwide experience with biosimilar development. mAbs. 2011;3(2):209-17. doi:10.4161/mabs.3.2.15005