Lower med standards endangers health Altoona Mirror Opinion Oct 2, 2024 Dr. Ralph McKibbin As a practicing physician in Pennsylvania, I firmly believe that the relationship between a doctor and their patient should guide every treatment decision. When physicians recommend treatments, we rely on years of training, clinical evidence, and the unique medical history of […]
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 […]
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 […]
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 […]
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 […]
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 […]
On March 19th, ASBM presented to the World Health Organization International Nonpropretary Names (INN) Expert Group at the 78th Consultation on International Non-proprietary Names for Pharmaceutical Substances (INN), held in Geneva, Switzerland on October 18th, 2023. ASBM was represented at the session by Executive Director Michael Reilly, Esq., and Advisory Board Chair Philip Schneider, MS, […]
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 […]
On January 31st, ASBM released a fact sheet describing a variety of proposed policy changes at the state and federal level which would weaken the interchangeable biosimilar standard, or circumvent the patient protections it provides. These include new bills and regulations at the federal level, as well as state legislation and proposals which threaten to […]
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 […]
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 […]
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, the substitution at the pharmacy level of a biosimilar without prescriber involvement. The automatic substitution of biosimilars is a controversial practice, banned in many countries including nearly […]
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 […]
Lower med standards endangers health Altoona Mirror Opinion Oct 2, 2024 Dr. Ralph McKibbin As a practicing physician in Pennsylvania, I firmly believe that the relationship between a doctor and their patient should guide every treatment decision. When physicians recommend treatments, we rely on years of training, clinical evidence, and the unique medical history of […]
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 […]
On August 20th, ASBM submitted comments on the FDA draft guidance for industry entitled “Considerations for Demonstrating Interchangeability with a Reference Product: Update”, published June 20th. This draft guidance describes considerations regarding a switching study or studies intended to support a demonstration that a biological product is interchangeable with a reference product. From ASBM’s comments: In addition to the FDA […]
ASCO 2024: ASBM Releases Resource Guide for Cancer Patients on IRA’s Impact on R&D, Access From May 31st – June 4th, the American Society of Clinical Oncology (ASCO) held its Annual Meeting in Chicago, IL. ASBM was well represented at the conference, with several member groups were in attendance including the International Cancer Advocacy Network (ICAN), […]
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.
