November 2, 2021
In October, the FDA finalized its guidance document “Questions and Answers on Biosimilar Development and the BPCI Act: Guidance for Industry”, addressing additional questions and answers related to biosimilar development. This is the second such revision to the guidance. The update added five questions, including: Sponsor responsibilities related to pediatric assessments for proposed biosimilar products The […]
October 25, 2021
On October 19th, ASBM participated in the World Health Organization’s 73rd Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances, held in Geneva, Switzerland. This was the seventeenth INN Consultation in which ASBM has participated. ASBM was represented by Executive Director Michael Reilly, Esq., and Advisory Board Chair Philip Schneider, MS, FASHP. While the discussions at the […]
September 30, 2021
On September 28th, 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 and is the third in the series “Biosimilars: What Pharmacists Need to Know”. The series is accredited by the […]
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 […]
September 30, 2021
ASBM Welcomes Ralph McKibbin, MD as Chairman In a Full Member Call September 9th, 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 is the fourth chairman since ASBM was […]
September 29, 2021
Madelaine Feldman Completes Term as ASBM Chair On August 31st, ASBM Chair Madelaine Feldman, MD, FACR completed her term as ASBM Chair. ASBM Executive Director Michael Reilly praised Dr. Feldman’s leadership: Dr. Feldman led ASBM during a difficult time, keeping ASBM engaged on important biosimilar policy issues during the COVID-19 pandemic. As […]
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 […]
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 […]
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 […]
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 […]
