Biosimilars Action Plan – FDA Seeks to Create a Dynamic Biologics Market

Last week, the U.S. Food & Drug Administration (“FDA”) released a Biosimilars Action Plan (“BAP”) with the objective of promoting innovation, competition and affordability of biologics and biosimilar products.  Characterizing the BAP as “an important piece of the Administration’s bold Blueprint to Lower Drug Prices,” the FDA underscored the need for a competitive market for biosimilars sooner, rather than later. “We’re not going to wait a decade or more for robust biosimilar competition to emerge.” FDA Press Release.

The BAP identifies the following “key strategies” along with “priority deliverables,” which the FDA believes will accelerate biosimilar competition:

Improving the efficiency of the biosimilar and interchangeable product development and approval process:

  • Development of application review templates for 351(k) Biologics License Applications (BLAs), so as to streamline the review process and enhancing public information about the FDA’s evaluation of biosimilar and interchangeable products.
  • Improving sponsor’s understanding of FDA’s evaluation of comparative analytical studies to demonstrate “biosimilarity” by creating resources such as development of an index of critical quality attributes for use in comparing proposed biosimilars to reference products.

Maximizing scientific and regulatory clarity for the biosimilar product development community:

  • Revising and providing additional guidance for further clarification of the regulatory pathway and facilitating better understanding of regulatory experience in other countries, along with exploring data sharing agreements with foreign regulators.
  • Enhancing the Purple Book to include more information about approved biological products, including information relating to reference product exclusivity determinations.

Developing effective communications to improve understanding of biosimilars among patients, providers and payors:

  • 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.
  • Engaging in a public dialogue with pharmacists and patients to resolve knowledge gaps and encourage stakeholder use of the FDA’s resources.

Reducing attempts to unfairly delay market competition to follow-on products:

  • Clarifying the FDA’s position on issues affecting reference product exclusivity.
  • Coordinate with the Federal Trade Commission to address anti-competitive behavior.
  • Working with legislators “to close any loopholes that may effectively delay biosimilar competition beyond the exclusivity envisioned by Congress.”

The BAP reflects the government’s agenda to reduce drug prices and improve access to medicine.  By creating a regulatory framework that offers an efficient approval process for safe and effective biosimilars, the FDA seeks to ensure fair opportunities for innovation and competition, which in turn will improve access and benefits to the consumer.