Latest News – Page 27 – Safe Biologics

FDA Launches Biosimilar Education Site for Prescribers

November 5, 2017

On October 23rd, the FDA launched a robust online resource center aimed at educating prescribers on biosimilars. The website includes fact sheets which explain regulatory terminology such as, “reference product” and “interchangeability”. The fact sheets also detail the biosimilar approval process as well as explain how these medicines are prescribed and substituted. Sections include: Biosimilar and Interchangeable Products; Biosimilar Development, […]

New York Becomes 36th State to Pass Biosimilar Substitution Law

November 5, 2017

On Monday, October 23rd, Governor Andrew Cuomo signed biosimilars legislation (S.4788A/A.7509A) regarding the pharmacy substitution of interchangeable biosimilar medical products—a measure ASBM and others have pursued in New York over the past two years. New York is now the 36th state to pass biosimilars substitution legislation. This law (Chapter 357 of the Laws of 2017) […]

New York Becomes 36th State to Pass Biosimilar Substitution Law

November 5, 2017

On Monday, October 23rd, Governor Andrew Cuomo signed biosimilars legislation (S.4788A/A.7509A) regarding the pharmacy substitution of interchangeable biosimilar medical products—a measure ASBM and others have pursued in New York over the past two years. New York is now the 36th state to pass biosimilars substitution legislation. This law (Chapter 357 of the Laws of 2017) […]

CMS Reverses Course on Shared Billing Codes for Biosimilars

November 5, 2017

On November 2nd, 2017, the Centers for Medicare and Medicaid Services (CMS) issued a final rule for the 2018 Physician Fee Schedule, which governs reimbursement rates for physicians. In a significant development, beginning in 2018 CMS will update payment for biosimilars. Under the previous rule finalized in 2015 under the Obama Administration, all of the biosimilars sharing one reference […]

ASBM Presents at 65th WHO Naming Meeting

October 20, 2017

On October 17th, ASBM Chair, Madeline Feldman, M.D., FACR; Advisory Board Chair, Philip Schneider, MS, FASHP; and Executive Director, Michael Reilly, Esq. appeared before the 65th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances in Geneva, Switzerland. ASBM has regularly appeared before the INN Consultation since 2013 and continues to advocate for distinguishable […]

Alliance for Safe Biologic Medicines Releases 2017 Canadian Prescriber Survey

October 17, 2017

For Immediate Release ~National survey reveals physician attitudes on key policy issues related to originator biologics and biosimilars ~ Ottawa, Ontario (November 22, 2017) A new national survey conducted by the Alliance for Safe Biologic Medicines (ASBM) found that Canadian physicians overwhelmingly support distinguishable names for all biologics, including biosimilars. Survey results also […]

Alliance for Safe Biologic Medicines Releases 2017 Canadian Prescriber Survey

October 17, 2017

For Immediate Release ~National survey reveals physician attitudes on key policy issues related to originator biologics and biosimilars ~ Ottawa, Ontario (November 22, 2017) A new national survey conducted by the Alliance for Safe Biologic Medicines (ASBM) found that Canadian physicians overwhelmingly support distinguishable names for all biologics, including biosimilars. Survey results also […]

ASBM Presents Poster at ESMO 2017

September 15, 2017

On September 10, 2017 ASBM presented a poster at the European Society of Medical Oncology (ESMO) 2017 Congress which presented perspectives of oncologists from 12 countries regarding biosimilar substitution. Responses were drawn from five recent ASBM surveys which gathered perspectives of more than 1,850 biologic prescribers in Australia, Canada, France, Germany, Italy, Spain, the United Kingdom, and the […]

ASBM Supports WHO Naming Plan in Comments to Australia’s TGA

September 12, 2017

On July 28th, 2017 the Australian Therapeutic Goods Administration (TGA) announced that it was seeking comments from interested parties on the nomenclature for biologic medicines, including biosimilars. In a comment letter dated September 7th, ASBM responded, advocating for distinct naming of all biologics and biosimilars, and urging the TGA to adopt the World Health Organization’s […]

ASBM Supports WHO Naming Plan in Comments to Australia’s TGA

September 12, 2017

On July 28th, 2017 the Australian Therapeutic Goods Administration (TGA) announced that it was seeking comments from interested parties on the nomenclature for biologic medicines, including biosimilars. In a comment letter dated September 7th, ASBM responded, advocating for distinct naming of all biologics and biosimilars, and urging the TGA to adopt the World Health Organization’s […]