January 14, 2019
by Philip Schneider, MS FASHP FFIP Advisory Board Chair, Alliance for Safe Biologic Medicines This is to clarify an irresponsible misrepresentation by Christopher Rowland in his article “Patients Stuck In Corporate Fight Against Generic Drugs,” published in the January 9, 2019 edition of the Washington Post. My comments that were misinterpreted in this article […]
September 27, 2018
On September 21st, 2018 ASBM submitted comments to FDA as a follow-up to September 4th Public Hearing “Facilitating Competition and Innovation in the Biological Products Marketplace”, at which three ASBM Chairs, and several Steering Committee members testified. The purpose of the hearing and the request for comments, is to seek input on how the FDA can achieve the following goals: […]
June 6, 2018
On June 4th, the U.S. Food and Drug Administration approved its eleventh biosimilar, Fulphila (pegfilgrastim-jmdb). This is the first biosimilar to Neulasta (pegfilgrastim) and is prescribed to decrease the chance of infection as suggested by febrile neutropenia (fever, often with other signs of infection, associated with an abnormally low number of infection-fighting white blood cells), […]
December 7, 2017
The Alliance for Safe Biologic Medicines conducts regular surveys to better understand physicians’ perspectives on originator biologics and biosimilars. The organization recently released its 2017 Canadian Prescriber Survey. The survey reveals Canadian physicians’ attitudes on a number of critical policy issues surrounding the approval and use of originator biologics and biosimilars. 83 per […]
May 2, 2017
On Friday, April 21st, the FDA approved its fifth biosimilar, Renflixis (infliximab-abda). While the second biosimilar approved for Remicade (infliximab)- the first being Inflectra (infliximab-dyyb), approved in April 2016. Renflexis is noteable as the first biosimilar to be approved without a meeting of an FDA Advisory Committee. Advisory committees provide FDA with independent opinions and […]
October 6, 2016
On September 30th, An op-ed appeared in the Detroit News, authored by Marcia Horn, President and CEO of the International Cancer Advocacy Network (ICAN), an ASBM Steering Committee member. Ms. Horn discusses how legislation permitting biosimilar substitution could help Michigan patients. Similar legislation has been passed in 25 states and Puerto Rico. A key provision […]
February 3, 2016
On February 2nd, ASBM’s Chairman Harry Gewanter and its Executive Director Michael Reilly participated in a panel discussion in Brussels, Belgium. The panel was held as part of a Labelling Workshop hosted by the European Biopharmaceutical Enterprises (EBE) and EuropaBio. Dr. Gewanter and Mr. Reilly discussed the findings of ASBM’s surveys of U.S. physicians and […]
November 20, 2015
On November 19th, ASBM participated in the Expert Patient Advocates and 21st Century Therapies Forum held in Toronto, Ontario. The forum was sponsored by the Canadian Organization for Rare Disorders (CORD), which works with governments, researchers, clinicians and industry to promote research, diagnosis, treatment and services for all rare disorders in Canada. ASBM Executive Director Michael Reilly joined a patient […]
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. […]
