Latest News – Page 11 – Safe Biologics

GaBI Journal Publishes Critical Review of Canadian Substitution Policies

September 30, 2021

On September 30th, the Generics and Biosimilars Initiative published GaBI Journal, Volume 10, 2021, Issue 3, containing 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 policies […]

ASBM Welcomes Ralph McKibbin, MD as Chairman

September 9, 2021

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

September 8, 2021

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

September 2, 2021

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

August 22, 2021

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 Whitepaper Offers Critical Review of Canadian Substitution Policies

August 22, 2021

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

July 31, 2021

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 […]

ASBM Letter to Congress Urges Level Playing Field for All Biologics

July 31, 2021

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

July 28, 2021

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 […]

FDA Approves First Interchangable Biosimilar Insulin

July 28, 2021

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 […]