Biosimilars Forum Applauds FDA and Commissioner Dr. Marty Makary for Supporting Safe, Effective and Lower-Cost Biosimilars
The FDA Will Accelerate Safe and Effective Biosimilar Development by Eliminating Unnecessary Bureaucratic Inefficiencies
Juliana M. Reed, executive director of the Biosimilars Forum, released the following statement following today’s updated Scientific Considerations Guidance from the U.S. Food and Drug Administration (FDA). The updated guidance, which outlines the FDA’s position—Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies—notes that routine CES will not be required for biosimilars and are not scientifically necessary.
“Now more than ever, it is clear that biosimilars—safe, effective, and lower-cost medicines that reference biologics—are key to fixing America’s healthcare affordability crisis. Nearly 30% of Americans say they have not taken their medication as prescribed due to unaffordable prices. Today’s updated guidance from the FDA and Commissioner Makary on biosimilars is a momentous, critical step in unlocking the potential of these modern treatments to lower prescription drug prices for all Americans.
“The Administration rightfully recognizes the importance of developing biosimilars efficiently based on science—rather than being slowed down by bureaucracy. Since 2015, the FDA has approved more than 70 biosimilars, and the Agency can now rely on the latest science and processes to approve biosimilars in a streamlined fashion. 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 decisive action from the FDA is also timely considering the looming ‘biosimilar void,’ which is a pressing, urgent situation that threatens the very viability of our industry. There are 118 reference biologics set to lose patent protection in the next decade, yet 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 which will only worsen the healthcare affordability crisis.
“While biosimilars have already saved the U.S. healthcare system $56 billion, there is the potential for so much more cost-savings. In fact, biosimilars can save an additional $181 billion in the next five years, including billions more in the Medicare program—only possible through commonsense policy changes like today’s.
“There is still more that can be done to ensure the promise of biosimilars becomes a reality for Americans. We are excited to continue working with the Administration and the FDA to help empower the FDA’s Office of Therapeutic Biologics and Biosimilars (OTBB) on additional policymaking, such as 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 Biosimilars Forum looks forward to continuing to work with Administration officials, the FDA and Congress to deliver lower-cost biosimilars for Americans. Time is of the essence—patients cannot wait longer.”
For more information on the Biosimilars Forum’s work to increase access to lower-cost biosimilars, visit biosimilarsforum.org.
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MEDIA CONTACT:
Scott Lusk
Signal Group, EVP