November 10, 2015
On November 10th, 2015 in Basel, Switzerland, ASBM’s Advisory Board Chair, University of Arizona pharmacy professor Philip J Schneider and ASBM Steering Committee Member Andrew Spiegel, Executive Director of the Global Colon Cancer Association, participated in a debate on the subject of distinguishable naming for biosimilars. The debate session, entitled “Naming conventions for biosimilar and […]
October 29, 2015
On October 27th, 2015, ASBM submitted comments on the FDA’s “Guidance for Industry Nonproprietary Naming of Biological Products”, released August 28th. The Draft Guidance called for distinguishable names for all biologic medicines, including biosimilars. This would be accomplished by use of a four-letter differentiating suffix composed of random letters. In the comments, ASBM commended the FDA for […]
October 16, 2015
Survey: Most Physicians Consider WHO Plan for Distinct Biologic, Biosimilar Names Helpful RIO DE JANEIRO, BRAZIL – The Alliance for Safe Biologic Medicines (ASBM) today shared the results of a survey examining the perspectives of 399 physicians distributed equally across four countries: Argentina, Brazil, Colombia, and Mexico. It was conducted in May 2015 and was […]
October 16, 2015
Survey: Most Physicians Consider WHO Plan for Distinct Biologic, Biosimilar Names Helpful RIO DE JANEIRO, BRAZIL – The Alliance for Safe Biologic Medicines (ASBM) today shared the results of a survey examining the perspectives of 399 physicians distributed equally across four countries: Argentina, Brazil, Colombia, and Mexico. It was conducted in May 2015 and was […]
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 […]
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 […]
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 […]
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. […]
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. […]
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 […]
