Progress Is Being Made Toward Approval Of Generic Biotechnology Drugs

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Generic Biotechnology Drugs

The U.S. slowly is makingprogress toward developing a regulatory pathway that would allow FDA toapprove generic versions of biotechnology drugs, experts from the generic drugindustry told attendees of the 10th annual International Generic Pharmaceutical Alliance conference in Miami Beach onThursday, the Miami Herald reports. Biotech products are more complicatedto re-create than traditional chemical-based drugs.


The U.S. is laggingcompared with other countries in allowing generic versions of proteins,vaccines, blood components and other biotech drugs, according to experts at theconference.

Kathleen Jaeger, president of the Generic PharmaceuticalAssociation, saidthat progress on the issue is being made in Congress because major employersincluding General Motors and Caterpillar are undertaking efforts to allowgeneric biotech drugs as a means to counter rising health care costs. Jaegersaid, "Everybody needs affordable health care," adding that U.S. roadblocksto approving generic versions of biotech drugs have set up "a monopoly inperpetuity" (Dorschner, Miami Herald, 11/30).

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