Biosimilars Forum Submits Comments to Accelerate Safe and Effective Biosimilar Development by Modernizing the FDA and Eliminating Bureaucratic Inefficiencies

Juliana M. Reed, executive director of the Biosimilars Forum, released the following statement on the Forum’s submitted comments to Office of Management and Budget (OMB) Director Russell Vought. The comments describe the Forum’s science-based recommendations to improve efficiencies around approving biosimilars at the U.S. Food and Drug Administration (FDA).

“The Biosimilars Forum submitted comments to OMB Director Vought on commonsense, necessary steps to optimize the FDA and eliminate inefficiencies in its biosimilars approval program. These recommendations are critical to achieving the Trump Administration’s priorities of accelerating the approval of biosimilars and eliminating unnecessary bureaucracy at federal health agencies.

“Safe, effective, and lower-cost biosimilars hold tremendous promise to significantly reduce wasteful spending in federal healthcare programs. Biosimilars have saved the U.S. healthcare system $56 billion, with the potential to save an additional $181 billion in the next five years. 

This savings includes billions in the Medicare program as prices continue to increase for expensive reference biologic drugs, which were 46% of U.S. prescription drug spending in 2022 despite only making up 3% of prescriptions.

“The Trump Administration, HHS, and the FDA must deliver on the biosimilars promise—while always following the science. The biosimilars industry and FDA have a decade of experience developing and  approving more than 70 biosimilars. Outdated and unnecessary steps delay biosimilar development and prevent Americans from accessing lower-cost medicines they need.

“Our recommendations include empowering the FDA’s Office of Therapeutic Biologics and Biosimilars (OTBB) with signatory approval on biosimilar reviews and applications to refocus the Agency’s resources to new, innovative medicines. This key office created the biosimilar industry in the U.S. from the ground up, and its personnel simply know the science best—and should be empowered. The FDA should also eliminate regulatory hurdles like 3-way pharmacokinetic (“PK”) studies and the biosimilar ‘suffix,’ which has no value to the safety or efficacy of biosimilars.

“The FDA biosimilar team has been forced to follow outdated, inefficient, and scientifically-unnecessary requirements that delay patient access to critical medicines. With support from the Administration, the FDA biosimilars team can create a more efficient scientific review process for biosimilars.

“Our comments also emphasize the time-sensitive nature of biosimilar development and approval. A typical biosimilar costs $100 million to $300 million to develop and takes six to nine years to go from the initial stages of development to FDA approval—requiring a major investment from U.S. companies. Our members take immense pride in this investment, and they must ensure their products are approved with efficiency to reach Americans that need them.

“This is especially pertinent as a ‘biosimilar void’ comes into view over the next decade, where of the 118 biologics set to lose patent protection in the next decade, only 10% have biosimilars in development. This biosimilar void threatens to leave patients without affordable alternatives, forcing them to rely on high-cost brand-name drugs.

“The Forum is greatly appreciative of the opportunity to share our recommendations that will allow U.S. developers to increase their development of lower cost biosimilars and bring greater savings to Americans. We look forward to working with the Administration and Congress on steps that are sensible for government efficiency, Americans in need, and cost-savings.”

For more information on the Biosimilars Forum’s work to increase access to lower-cost biosimilars, visit biosimilarsforum.org.

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