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.
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 Announcement of Medicare Drug Price-Setting List |
On August 29th, the Centers for Medicare & Medicaid Services (CMS) announced the first 10 drugs selected under its Medicare drug price “negotiation” plan, authorized by the Inflation Reduction Act (IRA) signed into law last year. Over the next 4 years, Medicare will set prices for up to 60 drugs covered under Medicare Part D and Part B.This shortsighted move won’t control costs and threatens to limit patient access to new medicines, ultimately resulting in worse health outcomes for U.S. patients, warns ASBM in a statement:
IRA Changes Break a Successful Program
Michael Reilly, ASBM Executive Director and former Associate Deputy Secretary in the U.S. Department of Health and Human Services, worked on the development and implementation of the Part D prescription drug benefit during his six years in the Secretary’s Office. While proponents of government price-setting in Medicare claim this will create savings and lower costs, Reilly disagrees:“Part D was designed following two decades of experience seeing government price-setting fail to control Medicare costs for services and healthcare provider rates. To avoid this happening with the new prescription drug benefit, we created a new model. Contrary to what many believe, under Part D, drug price negotiations do occur- they are conducted by pharmacy benefit managers (PBMs), and the law specifically forbid government interference in price-setting or formulary selection. As we intended, this approach has been incredibly successful in controlling costs: the Congressional Budget Office projected drug spending between 2004-2013 to be $770 billion; actual expenses were 45% lower- at $421 billion. It has a 90% approval rating among beneficiaries, premiums have held steady around $32/month since 2006, and it holds the distinction of being the only major federal program to ever come in under budget.”
A Better Reform: Ensuring Savings Are Passed Onto Patients
While price-setting proponents say beneficiaries will start to see lower drug prices beginning in 2026, there’s no evidence that this is true, and there are better ways to lower out-of-pocket costs- and much faster, Reilly explains. “Part D has been hugely successful in lowering costs- but these savings are not always being passed on to the patient by the PBMs. Thankfully, there is a broad bipartisan effort underway in Congress to rectify this and provide immediate relief for patients- this year, not in 2026.” No fewer than eight bills have been introduced or advanced out of committee this session, with bipartisan support, to address PBM rebate and pricing policies that result in higher drug prices for patients.
The Consequences of European-style Drug Price-Setting Policies
Not only will it fail to control costs, imposing European-style price controls on Medicare Part D will spell disaster for American patients in the coming years. Reilly remarks, “The U.S. leads the world in drug innovation and patient access precisely because we’ve rejected the kind of price controls that stifle R&D and delay drug availability in Europe and Asia.” For example:In the 1970s, European companies developed most new drugs; however, since the implementation of price controls in Europe, U.S. companies now produce 60% of new drugs, while European countries often have percentages in the single digits.90% of new cancer drugs are available in the U.S. within the first year, whereas fewer than half are available to cancer patients in Germany, the UK, France, and CanadaEuropean cancer death rates are 1.7 times higher than in the U.S.Reilly describes what European-style health outcomes might look like in the U.S: “Imagine if the U.S. had European cancer death rates. That would translate to an extra 420,000 cancer deaths annually. Europe’s drug price-setting is simply not a policy worth emulating, and American patients should be aware of its public health consequences.”Read the full ASBM Statement here.Read Axios coverage of the announcement here.
|Clips Now Available from ASBM & GaBI Webinar on Medicare Price Negotiation’s Impact on Innovation, Patient Access|
During August, ASBM shared a variety of video clips from the July 26 webinar MEDICARE DRUG PRICE NEGOTIATIONS: Impact on Healthcare Development and Patient Access to Medicines, hosted by ASBM and the Generics and Biosimilars Initiative (GaBI).
Clip 1: Medicare Part D Experts Discuss Inflation Reduction Act (IRA)’s Likely Effects – View clipThree 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 Services
Clip 2: Drug Developer Discusses Impacts on R&D – Steven Potts, PhD, MBA – View clip
Clip 3: Innovation and Patient Access – Andrew Spiegel, Esq. – View clip.
Clip 4: Panel Discussion – View clip. Full Webinar – View the full webinar here.
|FDA Approves First U.S. Biosimilar for Multiple Sclerosis (MS) |
On August 25th, the FDA announced approval of Tyruko (natalizumab-sztn) the first biosimilar to Tysabri (natalizumab) injection for the treatment of adults with relapsing forms of multiple sclerosis (MS). The biosimilar, like its reference product, is also indicated for inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn’s Disease (CD) with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of TNF-α (tumor necrosis factor, a substance in your body that causes inflammation). “Today’s approval of the first biosimilar product indicated to treat relapsing forms of multiple sclerosis furthers the FDA’s longstanding commitment to support a competitive marketplace for biological products and ultimately empowers patients by helping to increase access to safe, effective and high-quality medications at potentially lower cost,” said Sarah Yim, M.D., director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research. Tyruko (natalizumab-sztn) is the 42nd biosimilar approved by the U.S. FDA. Read more about the approval here.
|Eight Bipartisan Congressional Bills Seek to Regulate PBMs |
As of August 25, 2023, no fewer that eight bipartisan bills have been introduced or advanced out of Congressional committees that would restrict or change the practices of Pharmacy Benefit Managers (PBMs). As reported in Health Affairs, the bills focus mostly onfive key areas of PBM activities:TransparencySpread PricingRebatesOut-of-Pocket CostsPart DThe next step for many of the proposed bills is CBO evaluation of each of the bills and these proposals. These assessments will allow legislators to understand whether the new bills are projected to increase or decrease costs, and will likely help to determine eventual passage. Read the Health Affairs coverage of the bills here.
|Pill Penalty Will Devastate Cancer Research|
Writing in the Hartford Courant August 15th, Kenneth E. Thorpe warns of the devastating effects the Inflation Reduction Act’s “small-molecule penalty” will have on cancer research.Thorpe is Chair of the Department of Health Policy and Management at Emory University.
The small molecule penalty is forcing companies to pivot away from these sorts of breakthroughs — medicines that might otherwise have cut the cancer death rate and advanced the Cancer Moonshot. The CEO of Novartis, for instance, recently announced the company was nixing some cancer medications from its pipeline because it no longer made financial sense to pursue them post-IRA. Some are sounding alarms about the pill penalty’s impact on post-approval research. Oftentimes, companies find that an existing medication can treat another form of cancer years down the road. But successes like those require additional research, which can be costly. And many firms are realizing that, with only nine years to turn a profit, the math no longer adds up. Without a legislative fix, the IRA will be the Achilles heel of the critically important Cancer Moonshot. Luckily, that fix is relatively simple. Congress must afford small molecule drugs the same 13-year protection as biologics. Read the full article here. For more information about the IRA’s harmful effects on drug research and patient access to 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.
|Pharmacy Benefit Manager CVS Health Launches Biosimilar Subsidiary|
On August 23rd, CVS Health announced the creation of a wholly-owned subsidiary tasked with commercializing and co-producing biosimilars. The new company, called Cordavis, has already contracted with manufacturer Sandoz to market Hymiroz (adalimbumab-adaz) at an 80% discount to its originator product, beginning in Q1 2024.
CVS Health’s chief financial officer Shawn Guertin said: “Cordavis is a logical evolution for us and will help ensure sufficient supply of biosimilars in the US and support this market now and in the future while ultimately improving health outcomes and reducing costs for consumers.” The announcement comes as Congress and the Federal Trade Commission have been investigating the role of PBMs in rising medication costs. Read the announcement from CVS Health here.
Read more about the announcement here.
|ASBM Experts Discuss Interchangeable Biosimilars on AI Arthritis Podcast |
On August 6th, AI Arthritis released Episode 88 of its AI Arthritis 360 Talk Show, in which ASBM representatives discuss potential policy changes regarding interchangeable biosimilars and how they may undermine the patient protections currently in place. 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.
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. Under U.S. state law, only interchangeable biosimilars may be automatically substituted at the pharmacy level without physician involvement.
Listen to the podcast (audio file) Watch the podcast discussion (video file)
|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