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 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 8, 2014
ASBM Presents to WHO in Geneva On October 15, ASBM Chairman Dr. Gewanter and Executive Director Michael Reilly traveled to Geneva, Switzerland to participate in the World Health Organization’s (WHO) 59th International Nonproprietary Naming Stakeholders Session. The Geneva meeting was Dr. Gewanter’s first public appearance as ASBM Chairman, a role he assumed on September 1 […]
October 20, 2014
The Generics and Biosimilars Initiative (GaBI) recently published an article on IAPO’s Advocacy Toolkit on Biological and Biosimilar Medicines for Patients’ Organizations: The International Alliance of Patients’ Organizations (IAPO), which comprises over 200 patient groups and represents the interests of patients worldwide, has published an Information and Advocacy Toolkit on Biological and Biosimilar Medicines for […]
October 14, 2014
On October 12, BioCentury This Week did a special on FDA’s thinking about interchangeability, naming and other questions surrounding biosimilars with Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. The show also featured Dr. Mark McCamish, global head of biopharmaceutical development at the Sandoz unit of Novartis, and Geoffrey Eich, […]
October 9, 2014
ASBM recently showed support for the World Health Organization’s (WHO) draft Biological Qualifier (BQ) proposal by submitting comments to the WHO. ASBM and 14 of its members submitted comments on the BQ proposal released in July 2014, saying it is an encouraging step toward a naming system that will increase safety for patients around the […]
October 9, 2014
ASBM has traveled to cities around the world to participate in regulatory discussions on how to best achieve global safety standards for biosimilars. In August 2014, ASBM representatives took part in several meetings in Rio de Janeiro, Brazil for two different conferences. ASBM Chairman Dr. Harry Gewanter was a guest speaker at the August 13 […]
October 8, 2014
ASBM and Patient Groups Support WHO BQ Proposal In July, the World Health Organization’s (WHO) Programme on International Nonproprietary Names (INN) released their draft Biological Qualifier (BQ) proposal that would assign a four-letter alphabetic code at random to a biological active substance manufactured at a specific site. The WHO proposal outlined a plan for […]
October 1, 2014
A September 17 BioPharma article pointed out that almost all of the biosimilars currently approved have been developed using a third-party research organisation according to a survey from the Association of Clinical Research Organizations (ACRO). Read “Fastest Way to Biosimilar Approval? As the CRO flies” here.
August 14, 2014
The Alliance for Safe Biologic Medicines (ASBM), along with dozens of patient organizations, write Commissioner Hamburg to encourage the FDA to adopt a policy of distinguishable nonproprietary names for biosimilars and to issue guidance reflecting distinguishable naming as a priority for the well-being of patients. Read full letter here.
