Biosimilar Action Plan Introduced to Kick-Start the Biosimilar Market

July 20, 2018By Sara W. Koblitz

Though the pace of biosimilar approval has quickened substantially over the last year (with 6 approvals since this time last year alone), the biosimilar market remains sparse and slow. Unsurprisingly, FDA has noticed.  This week, FDA unveiled a Biosimilars Action Plan (BAP) aimed at speeding up approvals in an effort to enhance access to lower cost biologics.

Like the Drug Competition Action Plan announced about a year ago, Commissioner Gottlieb explained in remarks delivered at the Brooking Institution that the BAP seeks to preserve the “balance between innovation and competition” through “efficient, predictable and science-based pathways for drug review.” An FDA analysis discussed in these remarks showed that if American consumers had the opportunity to purchase successfully marketed FDA-approved biosimilar drugs, they could have saved more than $4.5 billion in 2017.

Dr. Gottlieb explained that even though biosimilars are new, biologic manufacturers have taken a page out of the small-molecule handbook and have adopted tactics to delay and frustrate biologic competition. Learning from the generic drug experience, the BAP applies many of the lessons learned from the implementation of the Hatch-Waxman Act to the biosimilar market.  FDA knows the tactics likely to be used: refusing to negotiate on REMS, patent evergreening, eroding public trust in the review process for biosimilars, and delaying biosimilar entry until potential manufacturers withdraw from an unprofitable market, and FDA is trying to strengthen its defense.  To this end, Dr. Gottlieb emphasized the use of carve outs in biosimilars and announced that FDA is developing a guidance to assist biosimilar manufacturers in carving out labeling information protected by patent.

With biologics representing 40% of all prescription drug spending, FDA is trying to better manage review and licensure pathways to facilitate competition and modernize policies to make review more efficient. The BAP focuses on four areas: efficiency of development and approval; scientific and regulatory clarity; effective communication; and reducing gaming of FDA requirements or other delays in competition.  As part of the BAP, FDA committed to encouraging innovation and completion and to taking action by:

  • Developing and implementing new FDA review tools, like standardized review templates for biosimilar and interchangeable products;
  • Creating information resources and development tools for biosimilar sponsors;
  • Enhancing the Purple Book to make it more useful;
  • Exploring data sharing agreement with foreign regulatory authorities to facilitate increased use of non-U.S-licensed comparator products;
  • Establishing an Office a Therapeutic Biologics and Biosimilars;
  • Continuing to provide education to health care professionals about biosimilar and interchangeable products;
  • Publishing guidances on biosimilar product labeling;
  • Providing additional clarity on demonstrating interchangeability;
  • Providing additional clarity and flexibility on analytical approaches to support a demonstration of biosimilarity;
  • Providing additional support to product developers regarding product quality and manufacturing processes; and
  • Engaging in public dialogue about the biosimilar program.

The promises on the list include the development of an enhanced Purple Book! It’s slated to be a “modernized, interactive user experience,” and will reportedly contain information beyond the current, which is basically just product name, BLA number, date of licensure.

Additionally, FDA has committed to holding public meetings and hearing, as well as prioritizing the development of guidance on various aspects of the Biologics Price Competition and Innovation Act. In fact, FDA released its first guidance of the BAP in tandem with the BAP announcement.  The guidance, Labeling for Biosimilar Products, explains that biosimilar product labeling should be predominantly the same as the reference product. However, modifications for safety information updates, Medication Guides, and additional conditions of use may be appropriate.

Information specific to the proposed biosimilar product should be included in the labeling only when necessary to inform the safe and effective use of the product by a healthcare provider. Data or descriptions from clinical biosimilarity studies should not be included.  The guidance even has detailed explanations for situations in which the biosimilar’s proprietary name, the biosimilar’s proper name, the reference product name, and the core name should be included in the labeling.  Approaches to specific sections of biosimilar product labeling, including a biosimilarity statement, are also described.  Finally, the guidance addresses FDA-approved patient labeling and revisions to biosimilar product labeling.

This guidance does not address labeling requirements for interchangeable products, as FDA will provide that in future guidance. But this does imply that more discussion on obtaining the brass ring, the interchangeable biosimilar, is hopefully forthcoming.