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  4. Public Meeting on Facilitating Competition and Innovation in the Biological Products Marketplace - 09/04/2018
  1. Speeches by FDA Officials

Speech | In Person

Event Title
Public Meeting on Facilitating Competition and Innovation in the Biological Products Marketplace
September 4, 2018

Speech by
Scott Gottlieb, M.D.

Remarks by Scott Gottlieb, M.D.
Commissioner of Food and Drugs
Public Hearing on Facilitating Competition and innovation in the Biological Products Marketplace

(Remarks as prepared for delivery)

Good afternoon and thank you for participating in today’s public hearing.

Information provided today, and submitted to the docket, will help FDA as we continue our work to foster a competitive marketplace of safe and effective biological products. 

We are committed to this work because of FDA’s vital role in supporting the innovation and ingenuity that provides patients with novel therapeutic options, while also helping to encourage a competitive marketplace that can make these therapies affordable.  While FDA is not directly involved in the pricing of drugs or biologics, FDA plays a key role in applying science-based policies to facilitate greater access to affordable therapies.

Biologics have become a crucial tool in the treatment of many serious and life-threatening diseases.  But the high costs of biologics are likely familiar to you by now: almost 40 percent of total prescription drug spending is on biologics.  Biologics represented 70 percent of the growth in drug spending between 2010 to 2015. 

We know it’s going to take more work to achieve a vibrant and competitive marketplace for biologics. And today’s public dialogue is an important part of that process. 

Congress, through the Biologics Price Competition and Innovation Act, gave FDA the authority to implement a pathway for approval of biosimilar and interchangeable products, and to balance innovation and competition.  In the past several years, substantial efforts have been invested to make this pathway successful.  FDA has developed the scientific and regulatory framework for the review of marketing applications for biosimilar products, incorporating the feedback from many diverse stakeholders.  Manufacturers have invested significantly in developing biosimilar products and the information needed to support approval.  This work yielded concrete results: the approval of 12 biosimilar products, including 6 approvals in the last year alone.

But I’m not satisfied with the current state of the biologics market. Even as we meet to discuss these important issues today, not even half of the biosimilars approved by FDA have entered the market. Each approved biosimilar product that is not yet marketed means lost potential cost savings from a biosimilar product that meets FDA’s rigorous standards but is not yet available to patients, not yet available to compete with the reference product.

I’ve expressed concerns that biosimilars are not being developed or submitted for approval because of marketplace dynamics that are viewed as unfavorable to biosimilars.  For instance, consolidation in the supply chain can work in favor the incumbent reference biologic and discourage adoption of biosimilar competitors.

We know there is more work to do at FDA to advance the science and policies to make the development of biosimilars more efficient, to increase the acceptance of biosimilars, and to avoid the regulatory gaming that can deter competition. 

That is why I announced FDA’s Biosimilars Action Plan a little over a month ago. To formulate this plan, FDA looked at how we could adapt the lessons learned from our regulation of generic drugs.  We looked to what we had already learned from our interactions with biosimilar sponsors during product development and application review.  We looked at how we could modernize our policies on the development of biosimilars to improve efficiency and increase regulatory certainty without compromising safety and effectiveness.  And we evaluated input from various stakeholders, such as professional societies and patient organizations. 

Under the Biosimilars Action Plan, not only are we making the biosimilar development and review process more efficient and predictable, but we’re also taking new steps to communicate with patients, payors, and providers to improve the understanding of biosimilar and interchangeable products. And we’ll act where appropriate to deter the gaming of FDA requirements to unfairly delay competition among biologics.  The Federal Trade Commission is a vital partner in this work and we look forward to continued coordination with them to address anti-competitive behavior in the drugs and biologics marketplace.

Our Action Plan is dynamic, and we continue to evaluate additional FDA actions that are needed to strike the appropriate balance between encouraging ongoing innovation in biologics while also facilitating the robust competition that can reduce costs to patients.

Thus, a key element of FDA’s Biosimilars Action Plan is to learn from stakeholders in today’s public hearing. It’s encouraging to see a diverse set of perspectives represented today.  In announcing today’s hearing, FDA solicited input from the public on a broad set of questions about how we should address complex and challenging questions related to FDA’s regulation of biosimilar and interchangeable products, while balancing innovation and competition.  We asked about areas where we see real potential to make the development and review of biosimilars more efficient and where we can clarify regulatory requirements for stakeholders.
And so, I’d like thank each of you for joining today and sharing your input and experience.  I’d also like to thank our staff for organizing this public hearing.  We at FDA will consider the information gathered through today’s hearing as we continue to identify new ways to facilitate competition and innovation in the biologics marketplace.  Thank you.

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