Latest News – Page 38 – Safe Biologics

ASBM Releases Pharmacist Survey; Findings Show Strong Support for Distinguishable Names for Biologics and Need for Transparency in Labeling

October 14, 2015

For Immediate Release: October 13, 2015 WASHINGTON, DC – The Alliance for Safe Biologic Medicines (ASBM) today released the results of a survey of 401 U.S. pharmacists showing strong support for distinguishable names for biologics and biosimilars and the need for more transparency in labeling. “This survey reinforces what ASBM has been hearing from pharmacists […]

ASBM Presents at 61st WHO Naming Consultation

October 13, 2015

Geneva, Switzerland – On October 13th, the Alliance for Safe Biologic Medicines (ASBM) presented before the World Health Organization’s (WHO’s) 61st Consultation on International Nonproprietary Names (INN). ASBM Chairman Harry L Gewanter, MD presented physician perspectives on biosimilar naming gathered from prescribers in eleven countries. This included data from ASBM’s recent survey of Latin American […]

CA Governor Brown Signs Biosimilars Bill

October 6, 2015

On October 6, California Governor Edmund “Jerry” Brown signed into law SB 671, which permits pharmacists to substitute an interchangeable biosimilar in place of its reference product, provided the pharmacist communicates the substitution to the physician within five days time so that an accurate patient record is maintained, and the physician has not indicated “do not […]

ASBM Presents to New York State Rheumatology Society

October 2, 2015

At the New York State Rheumatology Society 2015 Fall Meeting, held October 2nd in Saratoga, NY, ASBM presented a briefing entitled “Biosimilars: Regulatory Challenges and Physician Perspectives”. which discussed the current state of U.S. and international biosimilar regulation, including the topics of biosimilar naming, labeling, and substitution. ASBM shared survey data from physicans in eleven countries on these issues. Mr. […]

ASBM Presents to New York State Rheumatology Society

October 2, 2015

At the New York State Rheumatology Society 2015 Fall Meeting, held October 2nd in Saratoga, NY, ASBM presented a briefing entitled “Biosimilars: Regulatory Challenges and Physician Perspectives”. which discussed the current state of U.S. and international biosimilar regulation, including the topics of biosimilar naming, labeling, and substitution. ASBM shared survey data from physicans in eleven countries on these issues. Mr. […]

ASBM Statement on FDA Draft Guidance: “Nonproprietary Naming of Biological Products”

September 1, 2015

The Alliance for Safe Biologic Medicines commends the FDA for its leadership on biosimilars by releasing guidance that recognizes the need for all biologic medicines, including biosimilars, to be clearly distinguishable from one another. This clarity will aid in accurate product identification during prescribing, dispensing, and pharmacovigilance. Distinguishable naming is particularly important with the arrival […]

ASBM Conducts CE Course for Oregon Health System

August 1, 2015

On July 31, in Bend, Oregon, ASBM conducted a continuing education (CE) course for physicians, pharmacists, nurses, and other healthcare providers at six hospitals in the St. Charles Health System. Headquartered in Bend, Oregon, the system owns and operates St. Charles Madras, St. Charles Redmond, Pioneer Memorial Hospital, Blue Mountain Hospital, Lake District Hospital, and Harney […]

ASBM writes FDA on Need for Distinguishable Naming

July 20, 2015

In a letter dated July 20, 2015, ASBM Chairman Harry Gewanter, MD wrote FDA Acting Commissioner Stephen Ostroff MD on the need for all biologic medicines, including biosimilars, to be named so as to be easily distinguishable from one another. The FDA is expected to release its long-awaited guidance on biosimilar naming later this year. In […]

ASBM Welcomes Hepatitis Foundation International to Steering Committee

July 17, 2015

ASBM is pleased to announce the addition of Hepatitis Foundation International to its steering committee. The Foundation joins other patient and physician groups who help further the mission of organization which is to ensure the patient remains at the forefront of biologic and biosimilar policy making. The Hepatitis Foundation International is a 501(c)3 non-profit organization […]

ASBM, Patient Groups Write Australia on Proposed Substitution Policy

July 6, 2015

On May 26, 2015 Australian Health Minister Sussan Ley announced that Australia would become the first nation in the world to allow so-called “automatic” substitution of biosimilars by pharmacists in place of the biologic prescribed by a physician. This move came at the recommendation of Australia’s Pharmacy Benefits Advisory Committee (PBAC). In response to this development, ASBM and several […]