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
A government panel Wednesday took a major step toward approving a copycat version of a blockbuster cancer drug, paving the way for a new class of cheaper medicines that could save consumers billions of dollars. An expert Food and Drug Administration panel unanimously recommended that the government approve the drug known as EP2006, a lower-cost […]
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 6, 2015
On December 24, FDA Week quoted ASBM Executive Director, Michael Reilly, on how the upcoming January 7th FDA Meeting on Biosimilars will be an important opportunity for the FDA to hear from stakeholders. Read the full article Biosimilar Advisory Meeting May Offer Final Platform For Naming Debate here.
January 6, 2015
On January 6, the U.S. Food and Drug Administration (FDA) released its annual Guidance Agenda detailing which new and revised Draft Guidances will be issued by its Center for Drug Evaluation and Research (CDER) for 2015. Among them are four guidances pertaining to biosimilarity. Topics covered include: what data will be allowed for demonstrating biosimilarity, […]
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 […]
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 21, 2014
On November 18, Dr. Gewanter responded to a piece in The Hill by Citizens Against Government Waste, by pointing out that the author Tom Schatz, wrongly categorized biosimilar approval as a trade/competition issue when it is a really a patient safety issue. In his letter Dr. Gewanter wrote: As a practicing pediatric rheumatologist and chairman […]
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.
