safebiologics – Page 2 – Safe Biologics

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

December 20, 2023

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ASBM Comments on FDA Draft Guidance Removing Interchangeability Statement from Interchangeable Biosimilars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On November 17th, ASBM submitted comments to the Food and Drug Administration (FDA) on draft guidance released in September by the FDA.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 […]

October 2023 Newsletter

December 6, 2023

ASBM Statement: 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 […]

November 2023 Newsletter

December 3, 2023

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 […]

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.

September 2023 Newsletter

November 12, 2023

ASBM Whitepaper to Examine Impact of Medicare Drug Price-Setting on Drug Development, Patient Access The Journal of the Generics and Biosimilars Initiative (GaBI) is currently finalizing a whitepaper based on the July 26th webinar hosted by ASBM and GaBI entitled MEDICARE DRUG PRICE NEGOTIATIONS: Impact on Healthcare Development and Patient Access to Medicines. View the full webinar here or watch individual […]

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 […]

August 2023 Newsletter

October 10, 2023

ASBM Statement on Announcement of Medicare Drug Price-Setting List On August 29th, the Centers for Medicare & Medicaid Services (CMS) announced the first 10 drugs selected under its Medicare drug price “negotiation” plan, authorized by the Inflation Reduction Act (IRA) signed into law last year. Over the next 4 years, Medicare will set prices for up to […]