Fact Sheet: the IRA’s “Pill Penalty”

Click below to read ASBM member WeWorkForHealth’s Fact Sheet on the effects of the IRA’s “Pill Penalty”, also known as the “Small-Molecule Penalty”, which disincentivizes R&D on chemically-derived medicines used to treat many serious conditions like cancer and heart disease: Click below to view

Debunking Misinformation on Interchangeable Biosimilars

A recent IQVIA report funded by the generics industry trade group Association for Accessible Medicines is propagating several misleading claims about interchangeable biosimilars. ASBM has frequently addressed misinformation efforts about interchangeablity biosimilars in recent months, to correct the record and reinforce the rigorous FDA standards now protecting patient safety and treatment stability. Here are some […]

ASBM’s Dr. Feldman Participates in Capitol Hill PBM Forum

On February 25th, ASBM’s Immediate Past Chair Madelaine Feldman, MD FACR joined Members of Congress and other high-profile supporters of PBM reform at a Congressional event urging leadership to include critical bipartisan PBM reform legislation in the anticipated March funding package. The event, titled “Finish the Job! Pass PBM Reform Now” included welcome remarks from […]

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, taught a 2-hour class at the Ohio State University College of Pharmacy that examined how recent and proposed biosimilar policy changes may impact pharmacy practice within the biopharmaceutical industry.  The module examined three current policy issues related to biosimilars: Pharmacy students were given basic information about […]

Michael Reilly: Congress Should Maintain Current FDA Biosimilars Standards

Prioritize Patient Treatment Stability, Physician Confidence Michael ReillySeptember 25, 2024 Biologic medicines have revolutionized the treatment of serious chronic diseases including, arthritis, psoriasis, Crohn’s disease, and cancer. Nearly 10 years ago, the FDA approved the first “biosimilar” – a copycat medicine highly similar, but not identical to a previously-approved biologic. Biosimilars offer new treatment choices […]

ASBM Physician Survey on Interchangeable Biosimilars Finds Support for Maintaining Current Standards

U.S. Physicians Overwhelmingly Support Current FDA Data Standards, Switching Studies for Interchangeable Biosimilars; Oppose Pharmacy Substitution of Non-Interchangeable Biosimilars FOR IMMEDIATE RELEASE– September 4, 2024 Arlington, VA- U.S. physicians overwhelmingly support maintaining the Food and Drug Administration’s (FDA’s) current data standards for interchangeable biosimilars and oppose treating all biosimilars as interchangeable with the originator biologic […]

Analysis Finds Misinformation About Interchangeable Biosimilars Undermining US Health Policy, Physician Confidence, and Patient Health

WASHINGTON, July 16, 2024 – The Alliance for Safe Biologic Medicines (ASBM) announces the publication of a paper underscoring the critical role of the FDA’s interchangeable biosimilar data requirements in maintaining the safety and efficacy of biosimilar substitutions. Titled “Misinformation about interchangeable biosimilars undermines US health policy, physician confidence, and patient health,” the paper discusses the […]

ASBM’s Michael Reilly: Preserve the US Interchangeable Standard that Has Helped Drive Physician and Patient Confidence in Biosimilars

 In an April interview with EndpointsNews, an FDA official called on Congress to eliminate the distinction between biosimilars (which can be prescribed in place of their reference products by a physician) and “interchangeable” biosimilars, which can be substituted by pharmacists the way generics are. Doing so would undermine physician confidence in biosimilars and jeopardize treatment stability for many […]

ASBM Comments Urge EMA Not to Abandon Clinical Data in Biosimilar Approvals

On April 30, ASBM submitted comments to the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) as part of a public consultation period on the Agency’s “Concept paper for the development of a Reflection Paper on a tailored clinical approach in Biosimilar development”. The document expresses the EMA’s intent to streamline biosimilar development by […]

ASBM and GaBI Webinar Examines Policy Challenges to Interchangeable Biosimilars

On November 30, ASBM and the Generics and Biosimilars Initiative (GaBI) hosted Interchangeable Designation for Biosimilars- Ensuring Continuity of Patient Care: Upholding Interchangeability Status for Biosimilars. The webinar was the fourth in a series covering key health policy issues. The most recent of the webinars, hosted July 29th, examined the negative impact of the Inflation Reducation Act’s Medicare […]

GaBI Journal Publishes ASBM Whitepaper on Medicare Part D Price Setting 

In January, the Generics and Biosimilars Initiative (GaBI) published a whitepaper entitled “Medicare Drug Price Negotiations: Impact on Healthcare Development and Patient Access to Medicines”. The paper’s content is drawn from a webinar on the same topic hosted by ASBM and GaBI on July 26, 2023. It examines the likely negative effects of IRA’s price negotiation provisions, which allow the […]

More News
Debunking Misinformation on Interchangeable Biosimilars

Debunking Misinformation on Interchangeable Biosimilars

A recent IQVIA report funded by the generics industry trade group Association for Accessible Medicines is propagating several misleading claims about interchangeable biosimilars. ASBM has frequently addressed misinformation efforts about interchangeablity biosimilars in recent months, to correct the record and reinforce the rigorous FDA standards now protecting patient safety and treatment stability. Here are some […]

Fact Sheet: the IRA’s “Pill Penalty”

Fact Sheet: the IRA’s “Pill Penalty”

Click below to read ASBM member WeWorkForHealth’s Fact Sheet on the effects of the IRA’s “Pill Penalty”, also known as the “Small-Molecule Penalty”, which disincentivizes R&D on chemically-derived medicines used to treat many serious conditions like cancer and heart disease: Click below to view

ASBM Urges Congress to Support EPIC Act: Remove IRA’s “Pill Penalty” to Ensure Continued R&D for Small-Molecule Drugs

ASBM Urges Congress to Support EPIC Act: Remove IRA’s “Pill Penalty” to Ensure Continued R&D for Small-Molecule Drugs

On February 25th, the House of Representatives introduced the Ensuring Pathways to Innovative Cures (EPIC) Act (H.R. 1492) an important step toward fixing the Inflation Reduction Act’s (IRA) small molecule pill penalty. Small-molecule drugs typically come in pill or tablet form, and comprise 90% of prescriptions filled in the U.S. The Senate introduced its companion […]

ASBM’s Dr. Feldman Participates in Capitol Hill PBM Forum

ASBM’s Dr. Feldman Participates in Capitol Hill PBM Forum

On February 25th, ASBM’s Immediate Past Chair Madelaine Feldman, MD FACR joined Members of Congress and other high-profile supporters of PBM reform at a Congressional event urging leadership to include critical bipartisan PBM reform legislation in the anticipated March funding package. The event, titled “Finish the Job! Pass PBM Reform Now” included welcome remarks from […]

ASBM/Ohio State University College of Pharmacy Course Examines Impact of Lowering Interchangeable Biosimilar Standards, IRA

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, taught a 2-hour class at the Ohio State University College of Pharmacy that examined how recent and proposed biosimilar policy changes may impact pharmacy practice within the biopharmaceutical industry.  The module examined three current policy issues related to biosimilars: Pharmacy students were given basic information about […]

ASBM Responds to PCMA: Put Patients First, Not PBM Profits

ASBM Responds to PCMA: Put Patients First, Not PBM Profits

Press Release ARLINGTON, Va., December 9, 2024 (Newswire.com) – As the Senate moves this week to advance passage of the misleadingly named Biosimilar Red Tape Elimination Act (S. 2035), the Alliance for Safe Biologic Medicines (ASBM) reiterates its opposition to the self-interested efforts of the Pharmaceutical Care Management Association (PCMA), which strongly supports this bill that […]

Biosimilars 101

Biologic medicines are used to treat millions of patients with serious illnesses like cancer, arthritis, and psoriasis. The patents for many biologic therapies are expiring, and biosimilars are entering the marketplace. These give patients new treatment options, and reduce costs through competition. Regulatory authorities around the world have put policies in place to ensure that biosimilars have been appropriately tested, and are safe and effective for patients.

Non-Medical Switching
Non-Medical Switching is when a patient is switched from one biologic medicine (either an originator product or a biosimilar) to another product- not for reasons of health or safety but for economic reasons. This is often done by a third party such as a private insurer, a pharmacy-benefit manager, or a government agency in order to save money, increase profits, or because of a deal made with a particular manufacturer. This practice is controversial among patients and physicians because treatment decisions are not "one size fits all". Many patients try several biologic medicines until they find one that stabilizes their condition; physicians generally oppose the unnecessary switching of medicines for stable patients.

Member Partners

The Alliance for Safe Biologic Medicines is an organization composed of diverse healthcare groups and individuals—from patients to physicians, biotechnology companies that develop innovative and biosimilar medicines and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion.

logo logo logo