2025年美国仿制药与生物类似药节约报告

Letter From the President and CEO Top-line data highlights value and vulnerability across all generic markets It is a statistic that easily rolls off the tongue: In 2024, generics encompassed approximately 90 percentof all prescriptions filled in the U.S. but can be attributed to only 12 percent of drug spending. Simply put:Generics medicines save money. Let’s take it one step further. Generics are the only sector that consistently results indecreasedspending across the U.S. healthcare ecosystem. In fact, since 2019, the amount spent on all genericsales in the U.S. has declined by $6.4 billion, despite increased volume and new generic launches.1 For over a decade, AAM has partnered with The IQVIA Institute to capture relevant data and help describethe value of generic and biosimilar medicines in the U.S. Despite the hype and the discussion about drugpricing, the data shows an alarming but consistent trend. Alarmingly, it has been this way for the lastdecade. Since 2016, generic drugs have steadily made up nine out of every 10 prescriptions filled, all thewhile their overall percentage of costs has declined – from 27 percent in 2016 to only 12 percent in 2024.2 Does this mean the number of available generic drugs has decreased? NO! Americans are consumingmore and more of these lower-priced, high-value medications. As noted in the graph below, withrespect to generic oral solids (i.e., pills and capsules), the overall trend is an increased number of theseproducts being prescribed and sold. In 2015, the total number of generic oral solids was approximately167 billion. Within a decade (in 2024), that number increased to approximately 197 billion, a 15 percentincrease. Over ten years, Americans were prescribed and received nearly 2 trillion generic oral solids.Keep in mind, this figure does not include a host of other products made by generic manufacturers(e.g., injectables, creams, etc.). I N T R O D U C T I O N The question we must ask is clear: How then are drug prices still increasing? If the generics are loweringprices, then why are they higher overall? The answer is brand products and their increased pricing. In2018, it took eight different brand products to equal the total U.S. spending on ALL generic products.3Andin 2023, only two brand molecules – Ozempic and Humira – had a total cost that was greater than thecost spent on over 1,000 generic drugs combined. Unfortunately, right now little is being done to infuse sustainability into the generic marketplace. Asnoted in the graph below, compared to 30 years ago, generic drugs are launching at lower prices andbottoming out at lower prices. The biggest change has been increased savings through the use ofgeneric drugs. Thirty years ago, generic prices tended to stabilize at approximately 34 percent of thebrand product’s list price. In the last decade, that percentage has continued to drop – to 22 percent.This type of deflation can lead to unsustainable market conditions for generic drug manufactures anddangerously impact patient care. While the U.S. generic market is clearly in peril, solutions are not far out of reach. Policymakers muststreamline FDA processes, curb patent abuse, stop PBMs and Medicare policies from denying patientaccess, and rollback harmful federal policies – including IRA price controls. The time to act in the best interest of America’s patients is now! John Murphy IIIPresident and CEO, AAM Letter from the Biosimilars CouncilExecutive Director Sustainability is not guaranteed – we must double down efforts to ensure thebiosimilars market reaches its full potential This year, the biosimilars industry celebrated a decade of pathbreaking progress. This celebration wasmarked by many successes, including the expansion of biosimilar competition to new therapy areas(including bone and eye health), achieving $56.2 billion in savings for patients and the healthcare system,and 3.3 billion days of patient therapy. At the same time, the biosimilars market has not yet reached its full potential. A complex web ofsystemic barriers, including issues related to pricing and reimbursement, patent challenges, and outdatedregulatory requirements, continue to stymie the broader adoption of biosimilars. These challenges runthe risk of limiting biosimilar development in the future and diminishing the patient benefits realized frombiosimilar competition. Over the next decade, 118 biologics are expected to lose patent exclusivity, presenting a $234 billionopportunity for biosimilars. But right now, of these 118 biologics, only 12 molecules have biosimilars indevelopment. We characterize this lack of development as the ‘biosimilar void.’ I N T R O D U C T I O N Notably, asimilar analysisconducted in 2023 related to the European Union market noted that 73 percent(N=19) of high sales biologics would have a biosimilar in the pipeline. This is a sharp contrast to the 23percent (N=11) within the United States.4 Closing the biosimilar void in the U.S. wi