FDA Caution Tempers Race For Generic Biologics

Brad Fitzpatrick As the first biotech drugs begin to lose patent protection in the next few years, the US biotechnology industry is beginning to fear it will soon face price-cutting generic competition. Unlike the system for approving traditional, chemically based drugs, no regulatory process exists for the approval of generic versions of the newer bioengineered medicines. Many biotech executives had come to believe their products would enjoy monopolistic pricing even after their patents expir

Susan Warner
Oct 19, 2003
Brad Fitzpatrick

As the first biotech drugs begin to lose patent protection in the next few years, the US biotechnology industry is beginning to fear it will soon face price-cutting generic competition. Unlike the system for approving traditional, chemically based drugs, no regulatory process exists for the approval of generic versions of the newer bioengineered medicines. Many biotech executives had come to believe their products would enjoy monopolistic pricing even after their patents expired.

Generic copies of biological drugs could significantly lower healthcare costs for patients who can pay as much as $100,000 (US) a year for treatment. At stake is a chunk of an estimated $15 billion in sales of biotech drugs expected to lose at least some patent protection by 2005.

GENERIC INNOVATION Biotech companies argue that generic copies would create safety problems and stifle innovation and investment in an already high-risk industry. "What is important to us...

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