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Biologics LCM in the Biosimilar Age

Dr Duncan Emerton; Head of Biosimilars Practice, Datamonitor Healthcare Consulting

Biosimilars: a short introduction

Biosimilars are broadly defined as biological products that are “similar to, but not the same as” a reference biological product which is approved in a particular country or region, and the approval of which relies on, in part, data or information in an application for the reference biological product. Biosimilars can never be said to be exactly the same as the reference product, as can be said for small molecule, chemically synthesized generics, due to the way in which biologics and biosimilars are manufactured (i.e. by living cells and/or derived from animal tissues).

These critical differences between biosimilars and generics have prompted many to say that biosimilar developers can never properly copy a reference biological product, and thus ensure sufficient safety and efficacy of the final biosimilar product. Other “myths” that that have emerged in relation to biosimilars include poor quality, low capacity, and an inability to compete on price, to name but a few. Despite the obvious challenges developing biosimilar products, multiple approvals have been seen in the EU, US, Canada and Australia (Figure 1).

Figure 1: biosimilar (and complex generic) approvals in the US, Japan, EU, Australia and Canada (2006-2011). Data obtained from multiple sources.

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