In November, ASBM released two fact sheets on interchangeable biosimilars. Download them here: Physician Perspectives on Interchangeable Biosimilars Interchangeable Biosimilars: Comparing Europe and the U.S.
On November 6, 2023, 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. The policy change represents a stark […]
In a letter to Senator Mike Lee (R-UT) dated September 27th, ASBM urged the Senator to reconsider his support for S.6 “The Biosimilar Red Tape Elimination Act”, which would prevent the HHS Secretary from requiring switching studies in order for a biosimilar to be deemed “interchangeable”. Under U.S. state law, only interchangeable biosimilars are substitutable at the […]
September 11, 2023 The Centers for Medicare & Medicaid Services (CMS) recently announced the first 10 drugs selected under its Medicare drug price “negotiation” plan, authorized by the Inflation Reduction Act (IRA) signed in to law last year. Over the next 4 years, Medicare will set prices for up to 60 drugs covered under Medicare […]
On September 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 […]
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 which focused on unintended consequences for patient access that may result from the implementation of the Inflation Reduction Act (IRA). The webinar focused on the IRA’s price negotiation […]
On June 26th, ASBM Chairman Ralph McKibbin presented a poster at the DIA Global Annual Meeting in Boston, MA. The poster was based on the findings from ASBM’s Canadian ophthalmologist survey and compared the findings with those of other physicians surveyed in recent years. The surveys examined physician attitudes toward biosimilar substitution practices, pharmacovigilance and nomenclature standards, and different […]
By Michael Reilly, Executive Director, Alliance for Safe Biologic Medicines (ASBM) ASBM recently submitted comments to the Centers for Medicare & Medicaid Services (CMS) on the proposed Medicare Drug Price Negotiation Plan. Under this plan – authorized by the Inflation Reduction Act (IRA) signed in to law last year – Medicare will “negotiate” (set) maximum […]
The Ohio State College of Pharmacy has provided ASBM with access codes for our Members who wish to view the first four modules of the ASBM/OSU College of Pharmacy Biosimilars Course at no charge: Biosimilars Module 1: Introduction to Biologics and Biosimilars (Prof. Philip Schneider, MS FASHP FFIP) Biosimilars Module 2: Substitution and Interchangeability (Prof. Philip Schneider, MS FASHP […]
In November, ASBM released two fact sheets on interchangeable biosimilars. Download them here: Physician Perspectives on Interchangeable Biosimilars Interchangeable Biosimilars: Comparing Europe and the U.S.
On November 6, 2023, 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. The policy change represents a stark […]
In a letter to Senator Mike Lee (R-UT) dated September 27th, ASBM urged the Senator to reconsider his support for S.6 “The Biosimilar Red Tape Elimination Act”, which would prevent the HHS Secretary from requiring switching studies in order for a biosimilar to be deemed “interchangeable”. Under U.S. state law, only interchangeable biosimilars are substitutable at the […]
September 11, 2023 The Centers for Medicare & Medicaid Services (CMS) recently announced the first 10 drugs selected under its Medicare drug price “negotiation” plan, authorized by the Inflation Reduction Act (IRA) signed in to law last year. Over the next 4 years, Medicare will set prices for up to 60 drugs covered under Medicare […]
On September 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 […]
On June 26th, ASBM Chairman Ralph McKibbin presented a poster at the DIA Global Annual Meeting in Boston, MA. The poster was based on the findings from ASBM’s Canadian ophthalmologist survey and compared the findings with those of other physicians surveyed in recent years. The surveys examined physician attitudes toward biosimilar substitution practices, pharmacovigilance and nomenclature standards, and different […]
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.
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.
