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 Records Podcast on Inflation Reduction Act’s Medicare Drug Price Setting In December, ASBM and its member organization AI Arthritis recorded an episode of the AiArthritis 360 Voices podcast examining how the IRA’s changes to the popular and highly successful Medicare Part D prescription drug benefit will negatively impact patients in coming years. The episode was released December 27th.
The episode features three former government officials who worked on the development and implementation of Medicare Part D as well as two leading patient advocates. Participants discussed how the price-setting policy will result in fewer drugs being developed, reduced patient access to these medicines, and will likely fail to control costs as its proponents claim. 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 ClaptonVice 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, U.S. Department of Health and Human Services Tiffany Westrich-RobertsonCEO at the International Foundation for Autoimmune & Autoinflammatory Arthritis (AiArthritis) Andrew Spiegel, EsqExecutive Director, Global Colon Cancer Association; ASBM Steering Committee Member Listen to audio of the podcast here. View video of the podcast here.
|ASBM Submits Comments to Oregon PDAB Opposing Proposal to Permit Automatic Substitution of Non-Interchangeable Biosimilars
On December 13, Oregon’s Prescription Drug Affordability Board (PDAB) met to consider – and ultimately rejected – a proposal to permit the automatic substitution of non-interchangeable biosimilars; that is, their substitution at the pharmacy level without prescriber involvement. The automatic substitution of biosimilars is a controversial practice, banned in many countries including nearly all of Western Europe. Oregon state law currently only permits biosimilars that the FDA has approved as interchangeable to be automatically substituted. These have provided additional data demonstrating that safety and effectiveness do not diminish even after a patient is switched repeatedly between the reference product and the interchangeable biosimilar. Current law also requires pharmacies to inform patients if their medicine is being switched, but the proposed change would have eliminated this requirement. ASBM submitted comments opposing the proposal and defending the current state law. From the comments: As Congress and the FDA intended, the interchangeable biosimilar designation has proven successful in promoting confidence in biosimilars, and in their automatic and third-party substitution: 57% of physicians 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. States like Oregon were able to gain physician support for their biosimilar substitution legislation due to the assurances provided in the legislation that only interchangeable biosimilars would be substituted without prescriber approval. They were able to secure support from patient advocacy organizations conditional on patients being notified if their medicine were to be switched. The proposal under consideration by the PDAB strikes at the heart of these reasonable protections, and betrays the promises made to physicians and patients. Read ASBM’s full comments to the Oregon PDAB here.
|Comment Period Closes on CMS Proposal to Allow Medicare Part D Plan Sponsors to Substitute Non-Interchangeable Biosimilars In November, the Centers for Medicare and Medicaid Services (CMS) announced a Proposed Rule that would permit Medicare Part D plan sponsors to substitute non-interchangeable biosimilars in place of the biologic medicines now used to treat many chronic conditions such as rheumatoid arthritis, Crohn’s disease and cancer. Read ASBM’s statement on the announcement here. CMS accepted public comments on the Proposed Rule until January 5, 2024. ASBM was among the organizations which submitted comments. ASBM’s comments read, in part: Automatic substitution of biosimilars is highly controversial among physicians and is banned in many countries, including most of Europe. Proposing to change this standard in the U.S. not only undermines FDA regulatory guidance and the intent of the legislation passed by Congress and the entirety of our state legislatures, but also betrays the assurances given to patients, physicians, and other organizations who have supported the protections offered by biosimilar substitution laws nationwide. Beginning in 2013, all 50 states and Puerto Rico enacted legislation that allows for pharmacy-level, automatic substitution only for biosimilars given interchangeable status based on additional data provided to the FDA that demonstrates safe switching. Importantly, this legislation provided that all other biosimilars (i.e., those without an interchangeable status) would not be substituted at the pharmacy level without physician involvement or approval. State legislatures were able to gain support for permitting biosimilar substitution from medical societies and patient advocacy organizations nationwide, due to these assurances. While all FDA-approved biosimilars are safe and effective, the FDA’s concept of interchangeability ensures that switching decisions also account for the unique treatment needs of individual patients. Treatment plans are not one-size-fits-all. Chronic illnesses such as arthritis, Crohn’s disease, psoriasis, and various forms of cancer often require treatment plans tailored over years of trial and error with different products before a patient’s disease or condition is stabilized. Any change to a patient’s medication, including the automatic substitution of a biosimilar for the originator biologic without physician involvement, can pose a significant risk to patient stability.
The FDA’s interchangeability standard, with its extra data requirements, has proven successful in promoting physician and patient confidence in these medicines. A 2021 survey of US physicians representing 12 therapeutic areas revealed that 57% of them would be more likely to prescribe an interchangeable biosimilar, and 59% reported that an interchangeable designation makes them more comfortable with a pharmacy-level substitution of that biosimilar in place of the prescribed originator medicine. The dramatic change in policy proposed by CMS comes less than a year after a CMS Rule permitting Part D plan sponsors to substitute interchangeable biosimilars explicitly reassured the public it would not permit substitution of non-interchangeable biosimilars because they “have not met the requirements to support a demonstration of interchangeability.” Nothing has changed regarding non-interchangeable biosimilars since last year’s CMS Rule. Non-interchangeable biosimilars still haven’t met the FDA data requirements for interchangeability and still shouldn’t be substituted by a third party without physician approval. In summary, Section 8. Additional Changes to an Approved Formulary—Substituting Biosimilar Biological Products of the Proposed Rule stands in stark contrast to the opinions of the medical community, the wishes of patients, a decade of substitution policymaking across 50 states, the substitution policies of most advanced nations, and CMS’ own recent assurances. We respectfully urge CMS to reconsider and withdraw this rule. Read ASBM’s full comments on the proposed policy here.
Read ASBM’s statement on the announcement of the proposed policy here.
|Coming in January: ASBM Whitepaper on Negative Impacts of Medicare Part D Price Setting In January, the Generics and Biosimilars Initiative (GaBI) will publish a whitepaper entitled Medicare Drug Price Negotiations: Impact on Healthcare Development and Patient Access to Medicines.
The paper examines the likely negative effects of IRA’s price negotiation provisions, which allow the Centers for Medicare and Medicaid Services to negotiate prices of certain costly drugs, including many biologic medicines. The paper’s content is drawn from a webinar on the same topic hosted by ASBM and GaBI on July 26, 2023.
The paper’s authors include three former government officials worked on the development and implementation of Medicare Part D, the prescription drug benefit which is being modified by the IRA’s new price-setting provisions; as well as a prominent patient advocacy leader: Michael S Reilly, Esq; Executive Director, ASBMThomas 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 SciencesAndrew Spiegel, Esq; Executive Director, Global Colon Cancer AssociationThe paper will be both published online and in the print edition of GaBI Journal.
|How Inflation Reduction Act’s Price Setting Discourage Biosimilar Development and Reduce Price Competition
On December 15, the legal analysis site JD Supra published an article entitled “The Inflation Reduction Act’s First Potential Impact on Biosimilars”. The article examines the recent FDA approval of Amgen’s Wezlana (ustekinumab-auub) as an interchangeable biosimilar to Janssen’s Stelara (ustekinumab). Stelara was recently selected by the Center for Medicare & Medicaid Services (“CMS”) as one of the first 10 drugs subject to the Inflation Reduction Act’s (“IRA’s”) price negotiations. While the effects of price-setting on the development of new innovator biologics have been widely discussed, the article outlines how price setting for an originator biologic can also also discourage the development of biosimilars to these products: Because of price caps that the IRA will impose on Stelara, Wezlana will face a different competitive landscape than the six interchangeables for other drugs approved to date. Wezlana’s example calls into question whether the IRA will disincentivize the development of biosimilars for the most popular biologics at a time when more biosimilars are critical to reducing healthcare costs. The [Maximum Fair Price] imposed on Stelara during this time period will impact Wezlana’s profitability. Amgen presumably will offer Wezlana at a discount relative to Stelara. But in order to undercut Stelara’s MFP-capped price, Amgen will have to price Wezlana substantially lower than it would have if CMS had not selected Stelara. Getting more biosimilars on the market is widely viewed as critical to controlling the costs of biologics. HHS has reported pre-IRA price drops of up to 71% and 53% for biosimilars and their reference products, respectively. But the prospect of a reference drug being selected under the IRA could discourage drug companies from developing biosimilars to that reference drug. If that comes to pass, consumers will end up paying more for biologics over the long term. Read the full JD Supra article here.
|UPCOMING EVENTS WHO 78th INN ConsultationGeneva, Switzerland – March 19, 2024 ASCO Annual MeetingChicago, IL – May 31-June 4, 2024 DIA Global Annual Meeting
San Diego, CA – June 16-20, 2024