August 9, 2018

FDA Implements Biosimilar Action Plan to Boost Biosimilar Competition

By Leanne M. Rakers, Principal

With the goal of boosting competition in the biosimilar market, the FDA has released a 9-page “Biosimilars Action Plan” (BAP).  In introducing the BAP, FDA Commissioner Dr. Gottleib noted that “Competition is, for the most part, anemic.”  In fact, while the FDA has approved 11 biosimilars through 2018, only three are now marketed in the U.S.  Dr. Gottleib provided two main reasons for this lack of competition: supply chain consolidation (for example, rebating schemes) and litigation (for example, litigation involving patent thickets) which delay market entry.  To counteract this lack of competition, the BAP focuses on four key strategies:

  1. Improving the efficiency of the biosimilar and interchangeable product 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, providers and payors
  4. Supporting market competition by reducing gaming of FDA requirements or other attempts to unfairly delay market competition to follow-on products

The FDA states it is taking the following 11 key actions to support the 4 strategies:

  1. Developing and implementing new FDA review tools, like standardized review templates for biosimilar and interchangeable products
  2. Creating information resources and development tools for biosimilar sponsors
  3. Enhancing the Purple Book to make it more useful such as including exclusivity determinations
  4. Exploring data sharing agreements with foreign regulatory authorities to facilitate increased use of non-U.S-licensed comparator products
  5. Establishing a new Office of Therapeutic Biologics and Biosimilars (OTBB)
  6. Continuing to educate health care professionals about biosimilar and interchangeable products through outreach programs
  7. Publishing Guidances on biosimilar product labeling, such as the July 2018 Labeling for Biosimilar Products which explains that biosimilar product labeling should be predominantly the same as the reference product
  8. Providing additional clarity on demonstrating interchangeability
  9. Providing additional clarity and flexibility on analytical approaches to support a demonstration of biosimilarity
  10. Providing additional support to product developers regarding product quality and manufacturing processes
  11. Engaging in public dialogue about the biosimilar program

The FDA notes this is a crucial time in the emergence of the marketplace of biosimilar and interchangeable products.  The BAP was implemented to overcome barriers to market entry by facilitating the efficient development and approval of these products.

It will be interesting to see the effects of these strategies on the marketplace in the following years.