FDA: Make Way For Biosimilar Drugs

Published Online: Monday, May 16, 2011

Relief may be in store for patients and health plans saddled with the high costs of brand name biotech drugs. FDA officials reported in May that the agency expects to issue recommendations in 2011 to companies looking to market generic versions of biotech drugs, also called biosimilars.

The announcement was made by Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, at the Reuters Health Summit. Although the specific requirements are still under wraps, the FDA is “meeting with companies individually right now and giving them advice on their programs,” Dr. Woodcock told Reuters. “We are open for business,” she said.

The announcement coincided with a notice the FDA posted in the May 10 Federal Register requesting input from stakeholders on how best to develop a user fee program for biosimilars. Both moves show the agency is plowing ahead with provisions in the Patient Protection and Affordable Care Act (PPACA) that create an abbreviated approval pathway for biosimilars.

How soon the drugs will be available to consumers—and how much savings they will actually generate—remains unclear. The complexity of biotech drugs makes regulating generic versions an especially thorny task, and the agency’s industry guidelines will have to be individualized.

For example, Dr. Woodcock said that not all biosimilars will have to be tested in clinical trials with humans. “It depends on how confident you can be of the absolute sameness to the innovator product,” she said. “There’s a spectrum…some will get much closer than others in your ability to characterize them.”

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