FDA Commissioner Gottlieb Announces Biosimilars Action Plan

Realizing that something is very wrong with the speed of biosimilar access and uptake in the United States, Food and Drug Commissioner Scott Gottlieb announced a plan to address multiple factors slowing competition in these markets. He introduced his Biosimilars Action Plan in a webcast today hosted by the Brookings Institution.

“While less than 2% of Americans use biologics, they represent 40% of total spending on prescription drugs,” said Dr. Gottlieb.
“So, enabling a path to competition for biologics from biosimilars is a key to reducing costs and to facilitating more innovation.”

He stated, “Our Biosimilars Action Plan has 4 key strategies: Biosimilars Action Plan(1) improving the efficiency of the biosimilar and interchangeability development and approval process; (2) maximizing scientific and regulatory clarity for the biosimilar product development community; (3) developing effective communications to improve understanding of biosimilars among patients, clinicians, and payors; and (4) supporting market competition by reducing gaming of FDA requirements or other attempts to unfairly delay competition.”

The following specified elements of the Biosimilars Action Plan are taken directly from FDA’s website:

  1. Developing and implementing new FDA review tools, such as standardized review templates that are tailored to marketing applications for biosimilar and interchangeable products, to improve the efficiency of FDA review and enhance the public information about FDA’s evaluation of these products.
  2. Creating information resources and development tools for sponsors of biosimilar applications. This includes tools such as in silico models and simulations to correlate pharmacokinetic and pharmacodynamic responses with clinical performance. Such tools can make biosimilar drug development more efficient.
  3. Enhancing the Purple Book to include more information about approved biological products, including information relating to reference product exclusivity determinations.
  4. Actively exploring the potential for entering into new data sharing agreements with foreign regulators to facilitate the increased use of non-U.S.-licensed comparator products in certain studies to support a biosimilar application.
  5. Establishing a new Office of Therapeutic Biologics and Biosimilars to improve coordination and support of activities under the Biosimilar User Fee Act (BsUFA) program, accelerate responses to stakeholders and support efficient operations and policy development.
  6. Building on the FDA’s Biosimilar Education and Outreach Campaign, continue providing critical education to health care professionals, including releasing a series of videos that explain key concepts about biosimilar and interchangeable products.
  7. Publishing data and information should be included in the labeling.
  8. Providing additional clarity for product developers on demonstrating interchangeability, including by publishing.
  9. Providing additional clarity and flexibility for product developers on analytic approaches structure and function to support a demonstration of biosimilarity, including by publishing revised draft guidance on the use of data analysis methods, including statistical approaches.
  10. Providing additional support for product developers regarding product quality and manufacturing process, including by identifying physical product quality attributes that are most critical to evaluate, and by exploring ways to reduce the number of lots of the reference product required for testing.
  11. Engaging in a public dialogue through a Part 15 hearing and opening a docket to request additional information from the public on what additional policy steps the FDA should consider as we seek to enhance our biosimilar program.

In the coming days, we’ll analyze some of these elements and how they might (or might not) move the needle on biosimilar approval, marketing, and access.


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