Who We Are
The Alliance for Safe Biologic Medicines is an organization of patients, physicians, pharmacists, biotechnology companies that develop innovative and biosimilar medicines and others, who are working together to ensure that patient safety is at the forefront of the biosimilars policy discussion. It is the mission of the Alliance to serve as an authoritative resource center of information for the public, medical community, the FDA and other state and federal policymakers during the implementation of the biosimilars approval pathway and beyond.
Our Perspective
Biologics are advanced prescription drugs to treat cancer, rheumatoid arthritis and other debilitating diseases. In November 2010 the Food and Drug Administration began consultation with patient groups, physicians and industry on how to approve the first copies of these drugs, known as follow-on biologics or biosimilars. As the FDA moves forward in implementing this pathway, the Alliance for Safe Biologic Medicines will work to ensure patient safety remains the priority.
| ASBM Statement on CMS Announcement of 15 Additional Drugs Subject to Government Price Controls On January 17th, the Centers for Medicare & Medicaid Services (CMS) announced an additional 15 drugs that will be subject to price controls under the Inflation Reduction Act (IRA). This expansion continues a flawed policy that threatens innovation and jeopardizes patient access to critical treatments, including drugs vital for cancer treatment and popular new weight loss medications that have transformed the management of obesity and related conditions. “The IRA’s drug price controls are already hindering investment in critical drug research and development, undermining the innovation that has long made the U.S. a global leader in biopharmaceutical breakthroughs,” said Michael Reilly, ASBM Executive Director and former Associate Deputy Secretary in the U.S. Department of Health and Human Services. The consequences of the IRA’s “small molecule penalty,” which limits the time manufacturers have to recoup investments in simpler “small molecule” drugs like pills, are already being felt. Small molecule drugs make up over 90% of prescriptions filled in the U.S. and are essential for treating conditions such as cancer, heart disease, and neurological disorders. Yet, since the IRA’s implementation in 2021, investment in small molecule drug development has dropped by 70% as manufacturers shift resources toward biologics, which have more favorable financial incentives under the law. “By disincentivizing the development of these breakthrough therapies, the IRA puts the health of millions of patients at risk, now and in the future,” Reilly stated. Recent analyses underscore the harmful impact of the IRA’s policies. A recent IQVIA analysis of the first 10 drugs selected for price controls found that the federal government’s projected $6 billion in Medicare savings was overstated and misleading. Instead of reducing costs for patients, these price-setting measures are expected to increase out-of-pocket expenses for many beneficiaries. “ Read the full statement here. |
| Dr. Christina Beato: Lowering Interchangeable Biosimilar Standards Risks Patient Health, Physician Confidence On January 17th, the Albuquerque Journal published an op-ed by Dr. Christina Beato, former Assistant Secretary for Health and Human Services (HHS) on the topic of interchangeable biosimilar standards. In the piece, Dr. Beato shares her concerns with the recent policy push in Congress and the outgoing Administration to deem all biosimilars “interchangeable” upon approval, without additional data demonstrating the switch would not jeopardize patient stability, as is currently required. From the op-ed: Physicians overwhelmingly oppose these types of policies, and for good reason. A recent survey of doctors who prescribe biosimilars found that only 11% of physicians believe all biosimilars should be deemed “interchangeable.” Nearly 90% of doctors value the rigorous FDA review process for determining interchangeability and believe that the required studies are particularly important in building their confidence in biosimilar substitution. As a New Mexico physician and a former official at the U.S. Department of Health and Human Services (HHS), I was disheartened to learn that U.S. Sen. Ben Ray Luján, D-New Mexico, has supported efforts to loosen biosimilar standards. We must take steps to reduce health care costs, but cutting corners on safety protocols is not a solution. It’s a recipe for eroding quality, equity, and trust in our health care system. Patients deserve better, and New Mexicans expect their leaders to stand up for policies that protect their health and safety rather than undermine them. The current FDA standards for biosimilars have achieved a delicate balance of promoting innovation and equitable access to affordable treatments while maintaining high standards of safety and efficacy. This balance has given both patients and physicians the confidence to embrace these new medicines. Policies that override these standards threaten to unravel years of science-based progress. Read the full op-ed here. |
| RFK Jr., Nominee for Secretary of Health and Human Services, Advances in Confirmation Process Robert F. Kennedy Jr., President Trump’s nominee for Secretary of Health and Human Services, has successfully advanced past the Senate Finance Committee with a narrow 14-13 vote. He now faces a full Senate vote. Some of Kennedy’s stances- such as his support for an examination of the safety of ultra-processed foods, as well as synthetic dyes and additives- have garnered widespread support. However, the nominee has also received criticism about his views on other health policies such as vaccine safety. Kennedy has insisted that he is not “anti-vaccine” and has pledged not to ban vaccines under Trump. Kennedy has maintained that rather than banning vaccines, he intends to push for greater transparency surrounding their safety data. Read more about what to expect in the full Senate vote here. |
| New FTC Report Details How PBMs Inflate Drug Costs On January 14th, the Federal Trade Commission (FTC) released a second interim report highlighting alarming practices by the nation’s three largest pharmacy benefit managers (PBMs)—Caremark, Express Scripts, and Optum Rx. The report revealed dramatic price increases for specialty generic drugs, with some seeing markups of thousands of percent. These findings underscore the growing calls by patient advocacy organizations, physicians, and others for reform of controversial PBM rebate and formulary design practices criticized for driving up healthcare costs and restricting access to affordable medications. Key findings in the report show that the “Big 3” PBMs generated over $7.3 billion in excess revenue from specialty generic drugs between 2017 and 2021, achieving a staggering annual growth rate of 42%. Additionally, PBM-affiliated pharmacies were reimbursed at significantly higher rates than independent pharmacies, further disadvantaging unaffiliated competitors.The report also noted that plan sponsors paid $4.8 billion for specialty generics in 2021, while patient cost-sharing soared to $297 million. This report follows mounting federal scrutiny of PBMs, including congressional hearings and a prior FTC investigation and lawsuit over their role in inflating drug costs and undermining independent pharmacies. Read the FTC Report here. |
| PBM Reform: Could 2025 Finally See a Long-Awaited Overhaul? After years of mounting pressure from a broad coalition of stakeholders including patients, physicians, pharmacists, and pharmaceutical manufacturers, meaningful reform for Pharmacy Benefit Managers (PBMs) finally seemed within reach this past December. A federal funding bill originally included sweeping measures to mandate rebate transparency, prohibit overbilling Medicaid, and pass savings to Medicare sponsors—provisions that could have fundamentally reshaped the industry. However, the greatly stripped-down bill that was ultimately passed did not include these much sought-after changes, leaving reform advocates disappointed and the healthcare system unchanged. As PBMs face increasing scrutiny from lawmakers, regulators, and the public, 2025 presents another chance to address their controversial practices. With bipartisan momentum behind legislation like the PBM Act (which would force PBMs to sell their pharmacy assets) and ongoing Federal Trade Commission (FTC) lawsuits targeting industry giants over insulin pricing, could 2025 be the year that reform finally happens? A January 6th article in PharmaVoice takes a deep dive into how Congress and various regulatory agencies might rein in PBM practices in the coming year, and what a post-PBM reform drug distribution system might look like. Read the full story here. ASBM/Ohio State University College of Pharmacy Course Examines Impact of Lowering Interchangeable Biosimilar Standards, IRA On February 20th, Philip Schneider, ASBM Advisory Board Chair, will teach a 2-hour class at the Ohio State University College of Pharmacy that examines how recent and proposed biosimilar policy changes may impact pharmacy practice within the biopharmaceutical industry. The module will examine three current policy issues related to biosimilars:The likely negative impact of the Inflation Reduction Act’s price-setting on biosimilar development and commercialization; Proposed legislation (such as last year’s Biosimilar Red Tape Elimination Act) which would lower the requirements for interchangeable biosimilars and/or declare all biosimilars interchangeable and thus pharmacy-substitutable; and Various efforts to reform Pharmacy Benefit Manager (PBM) utilization management and formulary design practices. Pharmacy students will be given basic information about each proposal, then asked to research further and discuss challenges each policy might pose to increasing patient access to safe and affordable therapies. The course is the latest collaboration between ASBM and the OSU College of Pharmacy; which has included a 7-part comprehensive series on biosimilars, led by Professor Schneider and featuring ASBM Chairman Ralph McKibbin, MD; Immediate Past Chair Madelaine Feldman, MD, and ASBM Steering Committee Member Andrew Spiegel of the Global Colon Cancer Association. What Will 2025 Mean for Medicare Drug Price Setting Under the IRA? The Inflation Reduction Act’s (IRA) Medicare drug price negotiation program, while aimed at reducing costs, could have unintended consequences that reshape the pharmaceutical landscape. According to an article published January 10th in the legal news site JD Supra, the Maximum Fair Prices (MFPs) mandated under the IRA, with reductions as steep as 79%, could lead to ripple effects far beyond Medicare. Analysts warn of “spill-over” impacts on the private commercial market, as pharmacy benefit managers adjust formularies to compensate for reduced rebates. Moreover, the IRA may stifle innovation, with some companies cutting research pipelines and abandoning plans for follow-on drug indications.The law’s aggregation rules, which combine all drugs sharing an active ingredient under a single negotiation umbrella, further disincentivize investment in new formulations. The authors argue these provisions could “dampen incentives for additional research,” leaving patients with fewer treatment options in the long term. Manufacturers and patient advocacy organizations have challenged the IRA’s negotiation program through various legal claims, including First and Fifth Amendment challenges, but most cases have been dismissed on procedural grounds. However a 5th Circuit decision in September 2024 allowed a key case to proceed based on claims of economic harm and lack of proper notice-and-comment procedures, suggesting that litigation over the IRA could continue for years. In addition, with an incoming Republican administration and majorities in Congress, some provisions of the IRA may be up for debate. While a complete repeal of the law is unlikely, lawmakers could target controversial elements like the “orphan drug exclusion,” which discourages companies from expanding treatments for rare diseases, and the so-called “small molecule penalty,” which may disincentivize small molecule drug development. For more on the IRA’s evolving impact, read the full article here. Learn more about the IRA’s likely effects on patients at IRAPatientInfo.org ICYMI: Michael Reilly in RealClearHealth: Don’t Let a “Lame Duck” Congress Gamble with Patient Health On December 20th, RealClearHealth published an op-ed by ASBM Executive Director Michael Reilly discussing concerns that the Biosimilar Red Tape Elimination Act would lower standards for biosimilar medications. The opinion highlights concerns that this bill might be included in the end of year continuing resolution bill, without properly considering the impacts on patients. The bill would classify all biosimilars as interchangeable, allowing them to be substituted at the pharmacy level without physician approval, as if they were generics (which they are not). It would also remove the FDA’s authority to ask for additional studies when needed. Currently, biosimilar sponsors must demonstrate to the FDA that switching will not affect treatment safety or efficacy before third parties like insurers or pharmacy-benefit managers (PBMs) can substitute a biosimilar. The bill would remove these guardrails, Reilly explains: However, if passed, the Biosimilar Red Tape Elimination Act would classify all biosimilars as interchangeable without requiring additional analysis or data. Insurers and pharmacy benefit managers (PBMs) nationwide would be able to switch patients to their preferred – and often most profitable – products regardless of “interchangeable” designation. Inappropriate switching may affect treatment stability and safety for patients. Proponents of the bill have continuously cited alarming factual errors that suggest even the sponsors do not understand the science or the implications of this policy. The sponsors have falsely claimed that biosimilars are “equivalent” to generics; yet the FDA says, “biosimilars are not generics and important differences exist between them.” Supporters of the bill claim that clinical switching studies are required to substitute interchangeable biosimilars at the pharmacy when, in fact, the FDA has broad discretion on what data is required. A majority of interchangeable biosimilars were approved without such studies. Additionally, supporters of this bill incorrectly claim that loosening the standards for interchangeability will align U.S. policy with Europe. Contrary to what supporters of the bill claim, this policy will not align U.S. biosimilar regulations with those in Europe. The European Medicines Agency (EMA) refers to “interchangeability” as prescription substitutions by physicians and not third-party substitution of biosimilars at the pharmacy counter – a practice that is rare and frequently banned in European countries. U.S. physicians, who are experts in prescribing these treatments, overwhelmingly oppose the bill’s provisions. A recent survey found that 88% support individual evaluations for biosimilar interchangeability, and the same percentage see switching studies as essential to increasing confidence in these medicines. Only 11% of physicians support the FDA deeming all biosimilars as interchangeable without further data, as this bill would mandate. Read the full op-ed here. |
| FDA Approves a Record-Breaking 18 Biosimilars in 2024 In December 2024, the FDA approved its 63rd biosimilar, Steqeyma (Ustekinumab-stba). Steqeyma is a human IL-12 and -23 antagonist indicated for multiple immune-mediated diseases, including psoriasis (PsO), psoriatic arthritis (PsA), Crohn’s disease (CD), ulcerative colitis (UC) in adults, and PsO and PsA in pediatric patients 6 years of age and older. The approval of Steqeyma brings the total number of biosimilars approved in 2024 to 18, a record for the FDA. Eight of these approvals were for biosimilars whose reference products previously had no biosimilar competition. Read about the approval here. View all approved FDA biosimilars here. |
| UPCOMING EVENTS WHO 80th INN Consultation Geneva, Switzerland – March 18-21, 2025 DDNC Annual MeetingLos Angeles, CA – May 17-21, 2025 ASCO Annual MeetingChicago, IL – May 30-June 3, 2025 DIA Global Annual Meeting Washington, DC – June 15-19, 2025 BIO International Convention Boston, MA – June 16-19, 2025 |
