Potential of Biosimilars Can be Realized With a Strong, Well-Resourced FDA

Americans’ lives are impacted by the work of the Food and Drug Administration each and every day, whether they realize it or not. In countless homes, workplaces and health care settings, there is little understanding of the heroic efforts of a dedicated group of scientists, physicians and regulators pursue to ensure the safety of the food we eat, the medicines we take and health care procedures we undergo.

The FDA is responsible for safeguarding the nation’s food and drug supply, and protecting the public’s health and well-being. We are lucky here in the U.S., as our FDA is widely recognized for its expertise and competence and is considered the global gold standard for approval and oversight of safe medicines. We feel confident when we or our family members take an FDA approved medicine that it will be safe and produce the clinical effect that our doctor prescribed it for.

With this responsibility comes immense demands on the FDA’s resources and staff expertise.

In order to ensure that the FDA has the resources necessary to fulfill its mission and maintain its high standards, the agency and industry came together in to establish a partnership under the user fee programs. Today, the FDA and industry have user fee programs in areas such as prescription drugs, medical devices, generic drugs and biosimilar drugs. These cooperative agreements outline the funding support made by industry to the agency, with the approval and oversight of Congress, to help support the FDA’s work.

Since their inception, user fees have become a crucial source of financial support to the FDA, ensuring it is able to fulfill its critical mission. Today, user fees account for 43 percent of the FDA’s total funding. In the human drugs program, which oversees all drug approvals, user fees account for nearly 65 percent of the programs funding in fiscal year 2016.

Since their inception, user fee agreements have succeeded in giving the FDA the resources it needs to hire staff and invest in technology.  They have also reduced the time it takes for the agency to approve applications for important new drugs.

Today, the Energy and Commerce Health Subcommittee is considering the renewal of the Biosimilars User Fee Agreement for fiscal years 2018 to 2022, or “BSUFA II.” Through its work today, and moving forward this year, Congress has the chance to support the FDA, take steps in improving the public health of our nation, and promote scientific and medical innovation.

BSUFA II is especially important as biosimilars are a new class of biologic drugs that are intended to bring about market-based competition to directly address rising costs of reference biologics. This will help lower drug costs and increase patient access to these important medicines. Biologics represent some of the best-selling and most expensive drugs available in the market, which is why it is so critical to offer the public a more affordable alternative in the form of biosimilars.

The biosimilars industry is a new industry in the United States with great potential to lower drug costs.  For this potential to be realized, the FDA needs the resources necessary to hire and retain expert staff to properly oversee the biosimilars program. While there are currently only four biosimilars approved for the US market, the FDA has publicly stated that it has 64 active biosimilar programs in development for 23 different reference biologics. And more are expected in the future. Yet, to date, Congress has not appropriated any money for the FDA’s work on biosimilars. Instead, the FDA has been forced to reallocate more than $20 million in funds from other programs to support its work on biosimilars.

The commitments and proposed BSUFA II legislation will provide the necessary resources needed by the FDA to support a successful biosimilars program. Within BsUFA II there are significant enhancements to the Biosimilar User Fee program that support the review and approval of biosimilar medicines in the U.S. This will ultimately benefit patients by advancing biosimilar approvals and access in the U.S.  Highlights of the agreement include:

  • A revised review process meant to increase transparency and communication between the FDA and biosimilars sponsors that will facilitate an increase in the likelihood of first cycle approval.
  • Agency commitments to complete and publish several draft and final guidance documents that will provide industry with additional clarity and certainty regarding the biosimilars development and review process.
  • Agency commitments to augment and strengthen staffing of the biosimilars program and hiring of product reviewers.
  • And enhancements to the user fee structure and management that will allow greater transparency, predictability and long-term stability of biosimilar development programs in the U.S.

The changes in BSUFA II will result in improvements in communication and accountability between sponsors and FDA, and ensure BsUFA revenues are dedicated to the FDA’s biosimilars review program.  The agreement will help ensure timely and more transparent review of biosimilar products, to the benefit of patients who need these products.

I encourage Congress to support the BSUFA reauthorization and to provide the FDA with the necessary government resources it needs to continue building its biosimilar program. The commitments by the FDA, combined with the financial support of Congress and industry ultimately will benefit patients and help lower drug costs by getting these important products to market.


Juliana M. Reed is vice president for government affairs at Coherus BioSciences Inc. and serves as the immediate past president for the Biosimilars Forum.

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