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Lawmakers urge no delays for biosimilars


With tens and possibly hundreds of billions of dollars in potential savings still snagged in a regulatory limbo, federal lawmakers and health industry stakeholders strongly urged the Food and Drug Administration last month to knock down the final barriers to review and approval of biosimilar drugs for marketing in the United States.

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The call for the FDA to eliminate the final scientific and regulatory hurdles that have kept cheaper copycat versions of expensive biotech medicines off the U.S. market came at a Capitol Hill conference on biosimilars. Sponsored by Express Scripts and hosted by The Hill, a Washington-based news organization, the event on Dec. 4 featured talks by Sen. Richard Blumenthal, D-Conn., and Rep. Gus Bilirakis, R-Fla. Both lawmakers called for an end to the four-year delay in implementing an approval pathway for biosimilars.

Congress and the White House directed the agency to create an approval pathway for biosimilars with the enactment of the Biologics Price Competition and Innovation Act in 2010. The goal was to bring price competition to large-molecule bioengineered medicines that can cost tens of thousands of dollars a year. But FDA officials say their ability to issue clear guidance to pharmaceutical manufacturers on the application process has been slowed by budgetary constraints and the difficulty of reviewing and testing complex drug compounds derived from living tissue.

  Enough time has passed, said Bilirakis. “Since 2010, the FDA has been working on that path for the approval of biosimilar drugs, but the pathway has yet to be completed,” he told reporters and health advocates at the gathering. “Biosimilars have had remarkable international success. However, the pathway forward is not fully formed in the United States.”

“Widespread access to biosimilars can significantly reduce healthcare costs and increase access to affordable treatments,” said Bilirakis. “But ... there are roadblocks at each stage of the cycle in large part because of an outdated regulatory structure. This impacts medical device companies, physicians, clinicians and researchers. Ultimately, it negatively impacts patients.” “Too often, the regulatory structure in place gets in the way of innovation,” he added.

Senate Democrat Blumenthal agreed. “There are draft guidances for approval of biosimilars, but no final guidance,” he said. “And I think the FDA has an obligation to move as quickly as possible to establish those rules as to what would be required to test and assure safety and efficacy of biosimilar drugs.”

“I hope that in this exciting and promising innovative area, where lives are literally at stake, the government will move quickly and effectively to establish rules that enable approval of biosimilars and reimbursement of them, so that as many people as possible can have access to their tremendous potential,” Blumenthal said.

The discussion also included a talk by Dr. Steven Miller, SVP and chief medical officer at Express Scripts, and two groups of panelists who discussed the future for the biosimilar industry in the United States and the potential changes, including cost savings, that follow-on biologics could mean for the nation’s health system and for patients themselves.

“Specialty drug costs are going up about 20% year over year. At that rate, soon that 1% of prescriptions [dispensed in the United States] will [account for] 50% of total pharmaceutical spend,” Miller asserted.

“In Europe, we’ve had biosimilars for six years. And they’ve lowered the price of those specialty drugs between 30% and 50%,” added Express Scripts’ CMO. He said a study by ESI of 11 potential biosimilar products showed that “over the next decade, the savings could be $250 billion” if those products are approved.

Two companies already have submitted approval applications for biosimilars at the FDA without waiting for final guidelines, and others are sure to follow in 2015, said several speakers. “You’re talking about $23 billion in potential savings just for those two products over the next decade,” said Miller. “So the impact for pharmacy is profound.”

Panelist Sally Howard, deputy commissioner for policy, planning and legislation at the FDA, defended the agency’s lengthy delay in creating the scientific framework for an approval pathway, but voiced strong support for the eventual marketing and availability of biosimilars.

“We understand this is a significant market,” said Howard. “We’re thinking about patient safety and access. We do get the cost paradigm, as well, and we know that’s also important. But our focus is on patient safety, pharmacovigilance — the ability to track products in the event there is an adverse event, and the ability to report an adverse event.”

“We’re very supportive of this industry. We want to make sure that the way we proceed in everything we do builds confidence in these products ... so that this market is sustainable,” Howard said.

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