The FDA is planning soon to issue an explanation of its position on the scientific issues involved in getting follow-on biologic products into the market and give guidelines on how to do that. While some believe consumers will not see generic biologics for many years, others say the need for them may become more urgent if the cost of new biologics continues to rise and threatens the nation's health system. The biotech industry urges caution, saying science cannot yet ensure safe and effective generic versions of biotech drugs.

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