FDA announces Biosimilars Action Plan; industry applauds plan

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FDA announces Biosimilars Action Plan; industry applauds plan

By Sandra Levy - 07/19/2018
In an effort to advance paths to competition for biologics from biosimilars and to reduce costs for patients and our health care system, the Food and Drug Administration announced its Biosimilars Action Plan as part of the Trump administrations’ Blueprint to Lower Drug Prices.

In announcing the plan, FDA commissioner Scott Gottlieb said, “Our ability to build a market for safe, effective biosimilar products is key for patients and our nation’s healthcare system. It’s a key to promoting access and reducing healthcare costs. And it’s a key to advancing public health. But I’m worried that the market for these products still isn’t established. The ability for these products to penetrate clinical practice, and gain acceptance, is still not firm.”

Gottlieb continued, “That doesn’t mean that the future doesn’t hold a lot of promise for biosimilars. It just means that the future is uncertain. And the policy and regulatory decisions that we make today are going to have a lot to do with whether we realize the promise for this new category of products. Or if we see the opportunities we once envisioned go unrealized.”

Gottlieb went on to say, “We know that biologics are used to treat many serious and life-threatening diseases. They’ve become a mainstay in the treatment of cancer and autoimmune conditions. They’re also expensive. While less than 2% of Americans use biologics, they represent 40% of total spending on prescription drugs. By enabling a path for competition from biosimilars, we also give innovators an added incentive to invest in further research that’ll lead to the discovery of even better drugs that deliver additional benefits for patients.”

In outlining the plan, Gottlieb said it applies many of the lessons learned from its experience with generic drugs to accelerate biosimilar competition with four key strategies.

"First, improving the efficiency of the biosimilar and interchangeable product development and approval process. Second, maximizing scientific and regulatory clarity for the biosimilar product development community," he said. "Third, developing effective communications to improve understanding of biosimilars among patients, providers and payers. And fourth, supporting market competition by reducing gaming of FDA requirements or other attempts to unfairly delay market competition to follow-on products.”

Pointing out that biologics represent 70% of the growth in drug spending from 2010 to 2015, and they’re forecasted to be the fastest growing segment of drug spending in the coming years, Gottlieb said, "To make sure that the next generation of breakthroughs remains affordable, it requires vibrant competition from biosimilars. But it also means that we must consider new payment approaches. Models that allow us to take advantage of the competition that biosimilars offer. And so we need to adopt a different approach to paying for these drugs. An ideal system would reimburse biologics in a competitively bid scheme, where we could take full advantage of the multi-source competition.”

AAM Applauds FDA Plan

“The FDA’s Biosimilars Action Plan demonstrates a strong commitment from the agency to help deliver on the promise of biosimilars to America’s patients – one that our members share,” said Association for Accessible Medicine's president and CEO Chip Davis.

"The BAP is another key plank in FDA’s platform to ensure robust and timely competition from generic and biosimilar medicines that improve patient access and drive savings for consumers and the United States health care system," AAM said.

“The BAP, with its stated priorities including a focus on effective implementation of BSUFA II, stakeholder education, Purple Book improvements, finalization of the Interchangeability Guidance, and exploring the increased use of non-US licensed reference product in certain studies to support a biosimilar application, align closely to priority advocacy and education issues for AAM and its Biosimilars Council, as can be seen in AAM’s recent comments to the HHS Drug Pricing Blueprint to Lower Drug Prices and Reduce Out of Pocket Costs,” the organization said.

“While FDA acknowledges that many of the issues impacting biosimilars market access and competition are outside of its purview, we applaud the agency’s stated willingness to work across federal entities, including the FTC and Congress, to address anti-competitive behavior and statutory loopholes that are being exploited to delay biosimilar competition and patient access,” said Christine Simmon, AAM senior vice president, policy and strategic alliances, and executive director of AAM’s Biosimilars Council.