Viropro, Inc. (VPRO)

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A recent report by Allied Marketing Research predicts that the global sales of biosimilars will grow from $1.3 billion last year to $35 billion by 2020. The market in the EU is growing rapidly, but the U.S. market has not materialized as quickly as had been hoped, in part because of regulatory uncertainty and what would appear to be a higher than anticipated threshold for establishing clinical equivalence. Novartis just became the first company to file an application for the approval of a biosimilar under the FDA’s new regulatory guidelines, hoping to bring to the U.S. market a version of filgrastim (Neupogen®) that is currently sold in over 40 countries worldwide.