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Outside editorial: FDA should encourage medical innovation

Posted: February 15, 2012 - 1:00am

The following editorial appeared in the San Jose Mercury News:

Most Americans have no idea what biosimilars are, much less that they could save us $25 billion a year in prescription drug costs over the next 10 years.

Biosimilars are essentially generic versions of biologics, which are expensive, high-tech medications made from human or animal materials rather than chemicals. The worldwide market for biologics, including the cancer drugs Avastin and Herceptin, was just under $150 billion last year. The cost of developing these drugs averages about $150 million each, and the cost of treating patients with them runs into thousands of dollars.

After decades of study, the Food and Drug Administration last week released its first set of guidelines for bringing biosimilars to market. It strikes a good balance between lowering costs to consumers and maintaining the incentive for companies to keep up research and development of these wonder drugs.

New biologic drugs will have 12 years competition-free so they can profit from their lifesaving research. And biosimilars that follow will need to undergo extensive testing for effectiveness.

Europe already has a biosimilar market with knockoffs 20 percent cheaper than the original biologics. Americans need the same cost reductions, but the world needs the advances in health care that biologics bring. The FDA’s rules may need adjustment over time, but it’s good to get things rolling.

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