Strict standard urged for copies of biotech drugs

Amgen asks FDA to insist on proof of effectiveness

September 16, 2004|By BLOOMBERG NEWS

WASHINGTON - Amgen Inc., the world's biggest biotechnology company, urged the Food and Drug Administration yesterday to require proof of effectiveness before approving generic versions of protein-based medicines.

Drugmakers including Amgen and Teva Pharmaceutical Industries Ltd, the world's biggest maker of generics, presented arguments during a two-day meeting the agency called as it seeks to develop approval standards for generic biologic, or biotechnology, medicines. The treatments are based on proteins and are produced differently than are traditional medicines.

The FDA is considering standards after members of Congress told the agency to develop a generic-approval process to help lower costs. The federal Medicare health insurance program for the elderly and the disabled spends more than $1 billion a year on Amgen's Epogen for anemia, more than any other medication.

Drugs produced by biotechnology "are unique products," Kenneth Seamon, Thousand Oaks, Calif.-based Amgen's vice president for global regulatory affairs, told the FDA officers at the meeting in Gaithersburg. "They must be held to the same high standards of safety, purity and potency as the innovator to insure patient safety."

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