FDA Unveils Biosimilars Action Plan


FDA releases Biosimilar Action Plan

Scott Gottlieb

 The FDA rolled out an action plan designed to advance polices that will make the process for developing biosimilars more efficient.

At the Brookings Institution, FDA Commissioner Scott Gottlieb, MD, asserted that enabling a path to competition for biologics from biosimilars is key to reducing costs and to facilitating more innovation.

“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.”

The commissioner noted that although less than 2% of Americans use biologics, they represent 40% of total spending on prescription drugs.

“Our plan is aimed at promoting competition and affordability across the market for biologics and biosimilar products”

Gottlieb says that preserving the balance between innovation and competition would entail modernizing regulatory requirements to maintain efficient, predictable and science-based pathways for drug review.

“Our aim is to reduce the time, uncertainty, and cost of drug development, while also supporting a competitive market through the efficient approval of lower-cost generic, biosimilar, and interchangeable alternatives after the expiration of patents or other statutory exclusivities.”

Gottlieb pointed out that biologics represented 70% of the growth in drug spending from 2010 to 2015, and they’re forecasted to be the fastest growing segment of drug spending over the next several years.

“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, says Gottlieb.”

He asserted that the current payment system, which reimburses drugs based on their average sales price, was designed in a single-source world. “It was a market of biologics where there was typically only one drug in a category. And there wasn’t a lot of therapeutic variety or competition.”

He contended that a new approach was needed for 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.”

Gottlieb says that the biosimilars action plan applies many of the same lessons learned from the agency’s experience with generic drugs to accelerate biosimilar competition and includes four key strategies:

  • Improving the efficiency of the biosimilar and interchangeable product development and approval process.
  • Maximizing scientific and regulatory clarity for the biosimilar product development community.
  • Developing effective communications to improve understanding of biosimilars among patients, providers, and payers.
  • Supporting market competition by reducing gaming of FDA requirements or other attempts to unfairly delay market competition to follow-on products.

“I believe some of these actions can be transformative for sponsors’ ability to bring high quality biosimilars to market.”

As part of this effort, the FDA is seeking to strengthen its partnerships with regulatory authorities in Europe, Japan, and Canada. Such partnerships can enable greater efficiency in developing safe and effective biosimilars.

“And we’re also taking new steps to make the biosimilar development process more efficient.

Today, the FDA issued its final guidance on biosimilar labeling.”

“The FDA wants to make sure that biosimilar products have labeling that allows health care practitioners to make informed prescribing decisions for their patients. Our guidance gives recommendations to applicants on how to prepare this labeling for review by the FDA,” says Gottlieb.

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