October 31, 2025
TOPLINE
On Wednesday, U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., U.S. Food and Drug Administration (FDA) Commissioner Marty Makary and Centers for Medicare & Medicaid Services (CMS) Administrator Dr. Mehmet Oz made an announcement on accelerating biosimilar approvals, boosting competition and lowering prescription drug prices. The administration’s actions will include updated FDA guidance to eliminate comparative efficacy study requirements and streamline biosimilar approvals — a move that could significantly reduce barriers to fostering greater competition from more affordable alternatives to Big Pharma’s high-priced biologic drugs.
“CSRxP applauds the administration for taking steps to increase biosimilar competition and bring down costs for patients, taxpayers and the U.S. health care system,” said CSRxP executive director Lauren Aronson in a statement. “Actions to eliminate unnecessary red tape and streamline biosimilar approvals will help bring more affordable alternatives to market faster, boosting competition and delivering prescription drug savings for patients. [This] announcement represents an important step toward strengthening competition in the prescription drug marketplace, expanding access to safe, effective, lower-cost treatments, and holding Big Pharma accountable for blocking more affordable options.”
Read CSRxP’s full statement on the announcement HERE and read more about how biosimilar competition generates significant savings for American patients and the U.S. health care system HERE.
On Monday, the Institute for Clinical and Economic Review (ICER) released a new report which found that Big Pharma’s launch prices for prescription drugs newly entering the market continue to increase, without accompanying justification based on clinical value. According to ICER’s 2025 “Launch Price and Access Report,” the inflation-adjusted median annual list price for newly launched drugs increased 24 percent between 2022 and 2024. The report underscored these rising and unsustainably high prices tags are not justified by clinical value for patients. “The U.S. health system could’ve saved between $1.3 billion and $1.5 billion in just the first year post-approval” of these new medications if Big Pharma “stuck with the upper limit for price on what the watchdog suggested [would be justified by clinical value] prior to the launch of 23 drugs formerly reviewed by ICER.”
Read more on the new ICER report HERE.
QUOTE OF THE WEEK
“Since 2015, biosimilars have already saved Americans over $56 billion, $20 billion in 2024 alone. On average, biosimilars cost 50 percent less than their brand-name counterparts, and their entry into the market drives down brand-name prices by another 25 percent. That's real relief for patients, families, and for the American taxpayer.”
HHS Secretary Robert F. Kennedy Jr.
DATA POINTS YOU SHOULD KNOW
$308,749
The inflation-adjusted median annual list price for newly launched drugs in 2024 – according to a new report from ICER – a 24 percent increase from 2022.
TWEETS OF THE WEEK
@HHSResponse: “.@SecKennedy: ‘We’re cutting unnecessary red tape, reducing uncertainty, and making it easier for innovators to bring safe, affordable biosimilars to the market.’”
@DrMakaryFDA: “Biologics are 5% of prescriptions — but 51% of drug spending. @US_FDA is going to accelerate biosimilar alternatives to make these amazing medicines more affordable for Americans.”
ROAD TO RECOVERY
The New York Times: F.D.A. Moves To Speed Approvals For Cheaper Copycat Drugs
The Food and Drug Administration announced on Wednesday that it would ease regulatory roadblocks for low-cost copycat versions of certain medicines. Biosimilars, as the copycats are called, are seen as a crucial way to drive down drug prices. They are akin to generics of biologic drugs that are made through complex biological processes. Some well-known blockbuster drugs are now available as biosimilar competitors, including Herceptin, for breast cancer; Lantus, a widely used insulin; and Humira, for autoimmune conditions like arthritis.
STAT News: FDA Moves To Ease Path For Biosimilars As Trump Seeks To Cut Drug Costs
The Trump administration announced a draft framework Wednesday that officials say will speed cheaper versions of biologic drugs to market with the aim of making medicine more affordable and accessible for patients. The framework will shorten the path for the Food and Drug Administration to approve biosimilars, or copycat versions of biologic drugs, by lowering the clinical standards companies need to meet before bringing the drugs to market. That will cut the cost of developing biosimilars and the time needed to approve them, FDA Commissioner Marty Makary said at an announcement about the change. Makary said the agency plans to release its final guidance on biosimilars in three to six months.
Financial Times: US Set To Speed Up Generic Biological Drug Approvals
The US drugs regulator is preparing to accelerate approvals for cheaper generic versions of complex biological medicines, threatening to jeopardise revenue for some of the industry’s most profitable products. The US Food and Drug Administration is expected to take measures on Wednesday that include reducing the number of certain human clinical studies and cutting costs of medicines engineered with living cells. The changes would come despite fierce lobbying by the industry’s top representatives in Washington, who have spent millions of dollars to derail less-expensive biological options.
Inside Health Policy: CSRxP Applauds Administration For Commitment To Fostering Greater Biosimilar Competition, Lowering Drug Prices For American Patients
The Campaign for Sustainable Rx Pricing (CSRxP) today applauded an announcement by U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., U.S. Food and Drug Administration (FDA) Commissioner Marty Makary and Centers for Medicare & Medicaid Services (CMS) Administrator Dr. Mehmet Oz to accelerate biosimilar approvals, boosting competition and lowering prescription drug prices for millions of Americans.
PHARMA’S POOR PROGNOSIS
Inside Health Policy: ICER: U.S. Drug Launch Prices Continue To Rise, ICER Value-Based Approach Better Than MFN
A report from the Institute for Clinical and Economic Review (ICER) released Thursday (Oct. 23) found drug launch prices are rising at higher rates than inflation, gross domestic product growth (GDP) and health care costs, and if prices matched ICER’s value-based estimates, $1.3-1.5 billion could have been saved in the first-year pricing.
Law360: Whistleblower 'Horrified' By Novo Nordisk Drug Sales Tactics
The whistleblower behind a federal lawsuit accusing Novo Nordisk of paying kickbacks to doctors and patients as part of a scheme to drive sales of its hemophilia drug NovoSeven took the witness stand Monday, telling jurors she was "horrified" at how the drugmaker's marketing team targeted doctors. Jamie Siegel, a doctor on Novo Nordisk's clinical development team from 2008 to 2009, testified that she was pressured by the company to encourage her connections in the hemophilia community to promote off-label use of NovoSeven.
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