Manufacturing, regulatory complexities slow biosimilars

03/18/2013 | Genetic Engineering & Biotechnology News

Merck, Teva, Lonza and Samsung are among the companies that 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 can cost up to $250 million by some estimates and can take six to nine years, compared with $1 million to $2 million and three years for a generic small-molecule drug.

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