Latest News – Page 3 – Safe Biologics

ASBM Comments on FDA Draft Guidance Removing Interchangeability Statement from Interchangeable Biosimilars

December 19, 2023

On November 17th, ASBM submitted comments to the Food and Drug Administration (FDA) on draft guidance released in September by the FDA.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 […]

ASBM and GaBI Webinar Examines Policy Challenges to Interchangeable Biosimilars

December 8, 2023

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 Exhibits at ACR Convergence 2023

December 1, 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 […]

ASBM Releases Fact Sheets on Interchangeable Biosimilars

November 30, 2023

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.

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

November 12, 2023

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

September 27, 2023

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 […]

Medicare Price “Negotiations” Will Jeopardize Patient Access to New Medicines, Result in Worse Health Outcomes

September 11, 2023

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 […]

ASBM Experts Discuss Interchangeable Biosimilars on AI Arthritis Podcast

September 6, 2023

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 […]

Dr. McKibbin Presents Poster Session at DIA Global Annual Meeting 2023

July 20, 2023

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 […]

ASBM & GaBI Host Webinar on IRA Medicare Price Negotiations Impact on Innovation, Patient Access

July 13, 2023

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 […]