The Biosimilars Forum Thanks and Commends Trump Administration Healthcare Leaders for Supporting Lower-Cost, Safe and Effective Biosimilars
The FDA’s guidance to eliminate unnecessary bureaucracy is a monumental step in saving Americans hundreds of billions of dollars in healthcare costs
Juliana M. Reed, executive director of the Biosimilars Forum, released the following statement following the FDA’s formal issuance of new draft guidance—accompanied by a press release and fact sheet—on bringing lower-cost biosimilar drugs to Americans that need them.
“On behalf of myself and the Biosimilars Forum’s member companies, I applaud President Trump, Health and Human Services Secretary Robert F. Kennedy Jr., FDA Commissioner Dr. Marty Makary, Administrator for the Centers for Medicare & Medicaid Services Dr. Mehmet Oz, and all healthcare leaders throughout the Trump Administration for their bold leadership in advancing science-driven guidance on biosimilars. Their efforts will help Americans access lower-cost, safe and effective medicines they need.
“Biosimilars are a commonsense, bipartisan solution to skyrocketing prescription drug prices.
As the FDA’s press release and fact sheet detail—including Secretary Kennedy and Dr. Makary’s own comments on how biosimilars lower-costs—Americans deserve to be able to afford the treatments they need for serious conditions such as cancer, autoimmune diseases, diabetes, and more. With this guidance, the FDA has prioritized American patients who want access to affordable, safe, and effective medicines.
“Safe, effective, and lower-cost biosimilars are the clear answer to America’s skyrocketing prescription drug costs. 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.
“The FDA correctly cites the science it has accrued in its 76 biosimilar approvals to date, including processes to ensure the safety and efficacy of a biosimilar product. But unnecessary bureaucratic inefficiencies have slowed the development and approval of biosimilars for too long, hindering patients’ ability to afford the treatments they need for their every day life.
“The Biosimilars Forum wholeheartedly agrees with the FDA that this new guidance will bring a host of benefits to the American people, from introducing more competition, to giving patients choice of treatment, to lowering prescription drug costs. President Trump’s Administration noted today that this guidance could decrease the cost and time of biosimilar development in half.
“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 an excellent step in making biosimilars more readily available and accessible to patients. Challenges still remain in how biosimilars are treated by plans and PBMs, and we look forward to working with the Administration to address some of these pernicious issues, like doctors being financially penalized for prescribing a lower cost biosimilar product.
“For years, PBMs have blocked patients from having access to lower-cost medicines. Congress must address the PBM Monopoly. The three largest PBMs control more than 80 percent of the market, which means they determine what medications patients can take – not their doctors. The PBM system must be reformed. We all need to put Americans first, and PBMs are making patients pay more than they have to for medicines they need.
“This is especially pertinent as a ‘biosimilar void’ comes into view. Over the next decade, 118 biologics are expected to lose patent protection, and biosimilars could offer significant cost-savings for each of these. Unfortunately, only 10 percent currently have biosimilars in development, while 90 percent have no biosimilar in the pipeline. This void in the biosimilar market significantly limits savings potential to the healthcare system.
“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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