The approval last year in the EU of generic Remicade represents a milestone of sorts. Biosimilars aim to replace, or at least compete with, products that generated over $100 billion in worldwide sales in 2013. While Europe has led the way in the development of a regulatory pathway for the approval of such products, the US is not far behind.

While clearly an attractive market, biosimilars face two significant challenges in their effort to replace their respective incumbent branded biologics. First, they must persuade clinicians and patients that the product is equally safe and efficacious. Second — and possibly more challenging — they have to be “market similar.” That is — biosimilar manufacturers will need to offer the wrap-around market support programs that makers of branded biologics currently provide.

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