ASBM Welcomes Ralph McKibbin, MD as Chairman

ARLINGTON, VA- In a Full Member Call today the Alliance for Safe Biologic Medicines (ASBM) introduced gastroenterologist Ralph McKibbin, MD, FACP, FACG, AGAF as the organization’s incoming chairman. Dr. McKibbin began his three year term on September 1st, succeeding outgoing chair Madelaine Feldman, MD, FACR. Dr. McKibbin will be the fourth chairman since ASBM was founded in […]

ASBM Whitepaper Offers Critical Review of Canadian Substitution Policies

On August 22nd, the Journal of the Generics and Biosimilars Journal (GaBI Journal) published a new whitepaper by ASBM Executive Director Michael Reilly and Advisory Board Chair Philip Schneider. The paper is entitled “A Critical Review of Substitution Policy for Biosimilars in Canada” and highlights the stark contrast between the forced-substitution policies recently enacted by some Canadian provinces and the pro-competition […]

ASBM Presents to Malta Medicines Authority

On August 26th, ASBM’s Advisory Board Chair Philip Schneider gave a series of presentations at a Biosimilars Forum hosted by the Malta Medicines Authority in Valetta, Malta. Dr. Schneider provided an extensive overview of multiple topics related to biosimilars, including: Biosimilars: General Concepts (20 min) View here Biologic Nomenclature and the Importance of Non-proprietary Names […]

Substitution and Non-Medical Switching: What Pharmacists Need to Know

ASBM, in conjunction with the Long Island University College of Pharmacy (LIU-Pharmacy), is now offering a comprehensive continuing education course on biosimilars entitled “Biosimilars: What Pharmacists Need to Know”. The second course in the series,”Substitution and Non-Medical Switching” has been updated to include discussion of the July 28 approval of the first interchangeable biosimilar insulin. The course […]

ASBM Presents CE Course on the Biosimilar Market in 2021

On July 27th, ASBM Advisory Board Chair Philip Schneider presented an online Continuing Education (CE) course entitled the “The State of the Biosimilars Market in 2021”. The course was presented in conjunction with Long Island University College of Pharmacy (LIU-Pharmacy) and viewed by more than 150 pharmacists, mostly from the New York area. The presentation looked […]

ASBM Reviews Problems with Pharmacovigilance Programs and Biologics at DIA 2021 Global Annual Meeting

From June 27-July 1, 2021, ASBM virtually presented present a poster the DIA Global Annual Meeting 2021 entitled “A Review of Problems with Pharmacovigilance Programs and Biologics”. The poster is authored by ASBM Executive Director Michael Reilly and Advisory Board Chair Philip Schneider. Dr. Schneider presented the poster in a video recording available to conference attendees for the duration of the […]

Minnesota Budget Passes Without Biosimilar Provisions 

On June 29th, Minnesota Governor Tim Walz signed his state’s HHS Omnibus  budget for 2022-2023. The legislature had considered but ultimately rejected language aimed at boosting uptake of biosimilars – provisions which many patient groups believed might inadvertently increase out-of-pocket costs.   Since April, ASBM and other organizations including the Lupus and Allied Diseases Association (LADA, […]

ASBM Presents on Patient & Physician Perspectives at 15th Biosimilars Congregation

On June 24th, ASBM Executive Director Michael Reilly presented at the 15th Biosimilars Congregation. The event was organized to provide insight into the current state of play in the EU with respect to biosimilars and stimulate debate, in a multi-stakeholder setting, on the vital role of biosimilar medicines in the sustainability of healthcare systems. It also highlighted […]

Oklahoma Becomes Final State to Permit Biosimilar Substitution 

On April 22nd, Oklahoma Governor Kevin Stitt signed SB 4, making Oklahoma the 50th and final state to enact a law permitting biosimilar substitution. SB 4, like similar legislation in other states, permits interchangeable biosimilars to be substituted at the pharmacy level once approved by the FDA. Patients and physicians must be informed of a […]

More News
ASBM Welcomes Ralph McKibbin, MD as Chairman

ASBM Welcomes Ralph McKibbin, MD as Chairman

ARLINGTON, VA- In a Full Member Call today the Alliance for Safe Biologic Medicines (ASBM) introduced gastroenterologist Ralph McKibbin, MD, FACP, FACG, AGAF as the organization’s incoming chairman. Dr. McKibbin began his three year term on September 1st, succeeding outgoing chair Madelaine Feldman, MD, FACR. Dr. McKibbin will be the fourth chairman since ASBM was founded in […]

ASBM Presents to Malta Medicines Authority

ASBM Presents to Malta Medicines Authority

On August 26th, ASBM’s Advisory Board Chair Philip Schneider gave a series of presentations at a Biosimilars Forum hosted by the Malta Medicines Authority in Valetta, Malta. Dr. Schneider provided an extensive overview of multiple topics related to biosimilars, including: Biosimilars: General Concepts (20 min) View here Biologic Nomenclature and the Importance of Non-proprietary Names […]

Substitution and Non-Medical Switching: What Pharmacists Need to Know

Substitution and Non-Medical Switching: What Pharmacists Need to Know

ASBM, in conjunction with the Long Island University College of Pharmacy (LIU-Pharmacy), is now offering a comprehensive continuing education course on biosimilars entitled “Biosimilars: What Pharmacists Need to Know”. The second course in the series,”Substitution and Non-Medical Switching” has been updated to include discussion of the July 28 approval of the first interchangeable biosimilar insulin. The course […]

ASBM Whitepaper Offers Critical Review of Canadian Substitution Policies

ASBM Whitepaper Offers Critical Review of Canadian Substitution Policies

On August 22nd, the Journal of the Generics and Biosimilars Journal (GaBI Journal) published a new whitepaper by ASBM Executive Director Michael Reilly and Advisory Board Chair Philip Schneider. The paper is entitled “A Critical Review of Substitution Policy for Biosimilars in Canada” and highlights the stark contrast between the forced-substitution policies recently enacted by some Canadian provinces and the pro-competition […]

ASBM Letter to Congress Urges Level Playing Field for All Biologics

ASBM Letter to Congress Urges Level Playing Field for All Biologics

On July 28th, ASBM sent a letter to Congressional leaders expressing our  opposition to H.R.2815, the BIOSIM Act, a bill “to amend title XVIII of the Social Security Act to provide for a temporary payment increase under the Medicare program for certain biosimilar biological products to encourage the development and use of such products.” The bill proposes […]

FDA Approves First Interchangable Biosimilar Insulin

FDA Approves First Interchangable Biosimilar Insulin

On July 28th, the U.S. Food and Drug Administration (FDA) announced the long-awaited approved of the first interchangeable biosimilar, Mylan’s SemgleeⓇ. Under the Biologic Price Competition and Innovation Act (BPCIA) of 2009, which governs U.S. biosimilar development, an interchangeable biosimilar may be substituted in place of its reference product (in this case, Sanofi’s insulin glargine LantusⓇ) at the pharmacy without the […]

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 over the coming years, and biosimilars will be entering the marketplace. 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.

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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