By 2015, approximately USD73 billion of biologic sales are projected to lose patent protection, opening the door for the entry of biosimilar versions of these agents. The majority of agents losing patent protection within this time period are more complex biologics such as monoclonal antibodies (mAbs) and fusion proteins. Given the complexity and uncertainty of the biosimilar regulatory landscape in the developed markets -particularly the USA -as well as the high cost of clinical development in these markets, many potential biosimilar manufacturers are looking to the emerging markets (EM) as a high commercial opportunity. Success within these markets is driven by market issues unique to these markets.
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