Proceedings of the National Academy of Sciences (12/15/15) Vol. 112, No. 50, P. 15261; Ornes, Stephen

The Rand Corporation forecast last year that biosimilars will decrease overall direct spending on biologics in the United States by $44 billion over the next decade. In addition, Express Scripts predicts that the approval of 11 specific biosimilars would save $250 billion over the same time period. But it remains unclear how those savings will lower costs for patients, says Andrew Mulcahy of the Rand Corporation. The marketing of a biosimilar is likely to drive down the price of the reference product. However, because biosimilars are still new, much uncertainty persists. Interchangeability with the reference product is a major concern. Janet Woodcock, director of the Food and Drug Administration's Center for Drug Evaluation and Research, said at a Senate subcommittee hearing in September the agency is currently more concerned with verifying the science behind biosimilars and proving their safety and efficacy. Interchangeability will be an important next step after that. It could also take years to tweak the development process for biosimilars, because the manufacturing process is so complex. "I think there will be a rocky road for the first few biosimilars as they navigate these new processes," Mulcahy says. "Once we have 5 or 10 approved, and we're a few years out from now, things will settle down."

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