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 […]

ASBM Submits Comments Opposing CMS Proposal to Permit Medicare Part D Plans 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 […]

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 […]

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, 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 […]

ASBM Exhibits at ACR Convergence 2023

From November 12-14, ASBM exhibited at Booth #2612 at ACR Convergence 2023 in San Diego, CA. ACR Convergence is hosted annually by the American College of Rheumatology and is considered the premier meeting for rheumatology professionals globally. ASBM was represented at the booth by Executive Director Michael Reilly, Advisory Board Chair Philip Schneider, and Programs Director Ray […]

In Shocking Reversal, CMS Wants to Allow Medicare Part D Plan Sponsors to Substitute Non-Interchangeable Biosimilars

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 […]

ASBM Letter to Congress Defends Interchangeability Standard

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 […]

ASBM Members: Get Free Access to ASBM/OSU Biosimilars Course

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 […]

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EMA Seeks Public Comment on Re-evaluating the Need for Clinical Safety and Efficacy Data in Biosimilar Development

EMA Seeks Public Comment on Re-evaluating the Need for Clinical Safety and Efficacy Data in Biosimilar Development

On January 25, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) released a document entitled “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 re-evaluating the role of clinical safety and efficacy data; it also […]

GaBI Journal Publishes ASBM Whitepaper on Medicare Part D Price Setting 

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 […]

ASBM Submits Comments Opposing CMS Proposal to Permit Medicare Part D Plans to Substitute Non-Interchangeable Biosimilars

ASBM Submits Comments Opposing CMS Proposal to Permit Medicare Part D Plans 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 […]

ASBM Submits Comments to Oregon PDAB Opposing Proposal to Permit Automatic Substitution of Non-Interchangeable Biosimilars 

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, 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 […]

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ASBM Comments on FDA Draft Guidance Removing Interchangeability Statement from Interchangeable Biosimilars

On November 17th, ASBM submitted comments to the Food and Drug Administration (FDA) on draft guidance released in September by the FDA. The guidance removed the interchangeability statement from the product label/package insert of interchangeable biosimilars. Under U.S. state law, only interchangeable biosimilars may be substituted by a pharmacist without contacting the prescriber. This is due to […]

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.

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