Manufacturing, regulatory complexities slow biosimilars

03/18/2013 | Genetic Engineering & Biotechnology News

Several companies have scaled back plans to produce biosimilar versions of brand-name biologic drugs amid regulatory uncertainty, market volatility, and high development and manufacturing costs. Bringing a biosimilar to market costs up to $40 million by some estimates and takes up to nine years, compared with up to $2 million and three years for a generic small-molecule drug.

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