January 17, 2015
Randy Hillard was supposed to be dead by now. In 2010, the Michigan State University psychiatry professor was diagnosed with stage four stomach cancer and given less than a year to live. He started wondering how he could die in the most comfortable way possible given the circumstances, even briefly researching an assisted suicide organization […]
January 13, 2015
The controversial issue of biosimilar naming is seemingly absent from the FDA drug center’s 2015 guidance agenda as all signs point to the agency approving the first U.S. biosimilar by early March. The guidance agenda slates four biosimilar documents the agency plans to put out this year including one on labeling, but there is no […]
January 8, 2015
FDA Hosts Public Hearing on Biosimilars On January 7, ASBM members Global Colon Cancer Association (GCCA), Global Healthy Living Foundation (GHLF) and the Alliance for Patient Access (AfPA) all testified at the FDA’s Oncologic Drugs Advisory Committee (ODAC) public hearing on biosimilars. The patient groups expressed support for the pending approval, but also outlined […]
January 7, 2015
On January 7, Andrew Spiegel, executive director of the Global Colon Cancer Association and ASBM Steering Committee member, presented before the U.S. Food and Drug Administration (FDA) providing a patient perspective on why safety must be the ultimate priority when approving biosimilars. During his oral presentation before at the FDA’s Oncologic Drugs Advisory Committee (ODAC) public […]
January 3, 2015
From FDA Week: A handful of specialty physician groups are siding with the innovator biologics industry in urging FDA to adopt a biosimilar naming scheme under which products have distinguishable names, pushing back against arguments made by an American Medical Association council and generic drug makers for shared International Nonproprietary Names (INNs). The groups, like […]
December 11, 2014
On December 10th, ASBM Executive Director Michael Reilly presented the results from a new Canadian Survey at the Subsequent Entry Biologics in Canada: Current State of the Science workshop presented by the Canadian Society for Pharmaceutical Sciences and cohosted by BIOTECanada in Ottawa. The Canadian Physician Perspectives on Subsequent Entry Biologics (SEBs) survey, is a […]
December 8, 2014
Survey Presentation at Spanish Ministry of Health On November 25, Executive Director Michael Reilly presented the European Survey results at the “1st EuropaBio – ASEBIO Meeting on Innovation and Biological Therapies” at the Spanish Ministry of Health, Social Services and Equality in Madrid. The event was hosted by EuropaBio and the Spanish Bioindustry Association (ASEBIO) and […]
December 7, 2014
On December 2, Executive Director Michael Reilly presented the results from the European physicians survey at the DIA Biosimilars Conference in Berlin, Germany. The conference focused on current regulatory, scientific and market access perspectives for biosimilars and ASBM provided a physician’s perspective on biosimilars on the “Health Care Professionals’ and Patients’ Perception, Understanding and Experience […]
November 26, 2014
On November 25 in Madrid, Spain, the Alliance for Safe Biologic Medicines presented results from a survey of European physicians at the “1ST EuropaBio – ASEBIO Meeting on Innovation and Biological Therapies” at the Spanish Ministry of Health, Social Services and Equality. The event, hosted by EuropaBio and the Spanish Bioindustry Association (ASEBIO), included regulators […]
November 13, 2014
On November 12th Medscape posted an interesting video interview with FDA Commissioner Dr. Margaret Hamburg. Watch “FDA’s Hamburg on Balancing the Risks, Benefits for 310M Patients” here.
