Progress Is Being Made Toward Approval Of Generic Biotechnology Drugs

Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Pharma Industry / Biotech Industry
Article Date: 03 Dec 2007 - 12:00 PDT

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The U.S. slowly is making progress toward developing a regulatory pathway that would allow FDA to approve generic versions of biotechnology drugs, experts from the generic drug industry told attendees of the 10th annual International Generic Pharmaceutical Alliance conference in Miami Beach on Thursday, the Miami Herald reports. Biotech products are more complicated to re-create than traditional chemical-based drugs. The U.S. is lagging compared with other countries in allowing generic versions of proteins, vaccines, blood components and other biotech drugs, according to experts at the conference.

Kathleen Jaeger, president of the Generic Pharmaceutical Association, said that progress on the issue is being made in Congress because major employers including General Motors and Caterpillar are undertaking efforts to allow generic biotech drugs as a means to counter rising health care costs. Jaeger said, "Everybody needs affordable health care," adding that U.S. roadblocks to approving generic versions of biotech drugs have set up "a monopoly in perpetuity" (Dorschner, Miami Herald, 11/30).

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