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 & GaBI Webinar on Medicare Price Negotiation Examines Impact on Innovation, Patient Access On July 26th, ASBM and the Generics and Biosimilars Initiative (GaBI) hosted a webinar entitled MEDICARE DRUG PRICE NEGOTIATIONS: Impact on Healthcare Development and Patient Access to Medicines. The webinar focused on the IRA’s price negotiation provisions, which grant new authority to the Centers for Medicare and Medicaid Services to negotiate prices of certain costly drugs, including many biologic medicines. Presenters discussed the likely impacts of the legislation, as well as examining the effects government drug price-setting policies in different countries have had on patients. View the full webinar here or watch individual segments linked below. Medicare Part D Experts Discuss Likely IRA EffectsThree speakers who were deeply involved in the development and implementation of Medicare Part D, the program’s prescription drug benefit, discussed how it will be affected by the IRA changes. These speakers included:Thomas R Barker, Esq; Former Acting General Counsel of the US Department of Health and Human Services; Former Commissioner of the Medicaid and CHIP Payment and Access Commission (MACPAC) Charles Clapton,Vice President, Federal Government Affairs, Gilead Sciences; former Health Policy Director for the Senate HELP Committee and Former Chief Counsel for the House Ways and Means and Energy and Commerce Committees. Michael S Reilly, Esq; Executive Director, Alliance for Safe Biologic Medicines; former Associate Deputy Secretary at the U.S. Department of Health and Human ServicesView Mr. Reilly, Mr. Barker, and Mr. Clapton’s segment here. Drug Developer Discusses Impacts on R&D Steven Potts, PhD, MBA; CEO of Anticipate Bioscience is a cancer drug developer. Dr. Potts discussed how the IRA will reduce investment in drug research and development, particularly for small molecule drugs. View Mr. Potts’ segment here. Innovation and Patient Access Andrew Spiegel, Esq; Executive Director of the Global Colon Cancer Association, shared the patient perspective and highlighted the lifesaving value of innovation through personal stories of cancer patients. View Mr. Spiegel’s segment here. Other presenters included:Matias Olsen; Public Affairs & Policy Manager, EUCOPE, Belgium Philip Schneider, FASHP, FFIP Past Vice President, International Pharmaceutical Federation (FIP) The event concluded with a panel discussion and Q&A. View the panel discussion here. |
| ASBM Launches Microsite on Medicare Drug Price Negotiation On July 26th, ASBM launched IRAPatientInfo.org, a microsite dedicated to educating patients, healthcare professionals, and the general public about the Inflation Reduction Act (IRA)’s harmful impacts on drug development and research, as well as the likelihood of reduced patient access to lifesaving medicines. Visit IRAPatientInfo.org IRAPatientInfo.org is a central online educational resource containing news articles, infographics, videos, webinars, and other materials patients can use to learn about this policy’s likely effects on innovation and patient access. Check back frequently, as ASBM will continue to update the site as new articles and additional resources become available. |
| ASBM Discusses Importance of the Interchangeable Biosimilar Designation on Ai Arthritis Podcast On June 28th, ASBM recorded an episode of the AI Arthritis 360 Talk Showdevoted entirely to the issue of interchangeable biosimilars and how new policies may undermine the patient protections currently in place. A biosimilar standard unique to the U.S., an interchangeable biosimilar has provided additional data to the FDA which demonstrate that not only is the product safe and effective, but that any given patient can be repeatedly switched between it and the reference product and expect the same result, without additional risks. Listen the the podcast (audio file) Joining Ai Arthritis Executive Director and host Tiffany Westrich-Robertson were ASBM Executive Director Michael Reilly, ASBM Chairman Ralph McKibbin MD FACP FACG AGAF, and ASBM Steering Committee Member Andrew Spiegel, Executive Director of the Global Colon Cancer Association. Watch the podcast discussion (video file) Under U.S. state law, only interchangeable biosimilars may be automatically substituted at the pharmacy level without physician involvement. The panel examines recent statements and legislation which threaten to undermine the interchangeable designation in different ways, and discuss how patients and physicians can help preserve the protections it offers patients. |
| Senate HELP Bill Would Declare All Biosimilars Interchangeable In early September, the Senate Committee on Health, Education, Labor, and Pensions (HELP) will begin markup on the Primary Care and Health Workforce Expansion Act, a bill aimed at relieving a shortage of healthcare workers. Buried within this bill however, is a provision which would declare all biosimilars to be “interchangeable”, effectively rendering meaningless the interchangeable biosimilar designation as set forth by the Biologics Price Competition and Innovation Act of 2009 (BPCIA) and nearly a decade of FDA Guidance. Were this provision to pass, it would undo more than a decade of hard-won progress in building physician and patient confidence in the safety and efficacy of biosimilar medicines. As intended, the interchangeable biosimilar designation has built physician and patient confidence as price competition has generated substantial savings to our health system. A 2021 survey revealed that while 89% of U.S. prescribers have high confidence in the safety and efficacy of biosimilars, a majority (58%) oppose third-party switching of a patient’s biologic medicine for non-medical (e.g. cost, coverage) reasons. Yet the interchangeable biosimilar designation has proven successful in promoting confidence in automatic and third-party substitution among a majority of physicians: 57% said they’d be more likely to prescribe an interchangeable biosimilar; 59% said that an interchangeability designation makes them more comfortable with a pharmacy-level substitution of a biosimilar in place of the originator. Weakening the interchangeable biosimilar standard by applying it to all biosimilars -including those which have not provided additional data- would have immediate and harmful effects nationwide. Beginning in 2013, all 50 states and Puerto Rico enacted legislation that allows for automatic substitution of interchangeable biosimilars at the pharmacy level without the need for physician involvement or approval. Automatic substitution of biosimilars is highly controversial among physicians for the reasons mentioned, and is banned in many countries including most of Europe. The U.S. laws were passed with the support of state medical and pharmacy societies as well as national and state patient advocacy organization, contingent on the understanding and expectation that only interchangeable biosimilars—those that have demonstrated safe switching through additional data provided to the FDA—would ever be substituted without physician involvement. ASBM will continue to monitor the progress of this legislation. |
| UPCOMING EVENTS WHO 77th INN Consultation Geneva, Switzerland – October 17, 2023 World Drug Safety Congress AmericasBoston, MA – October 18-19, 2023ACR Convergence 2023 San Diego, CA – November 10-14 |
