November 10, 2014
Rep. Bobby Rush: “Biosimilars – Another Untold Story of the Affordable Care Act” In a November 6, oped for the Huffington Post, Rep. Bobby Rush (D-Ill) made the case for physician- pharmacist communication when it comes dispensing biosimilars. He wrote: “While the nuances of the legislation and rules considered in each state may vary, one […]
November 5, 2014
BOSTON, Massachusetts- On October 20-22, 2014, ASBM members John Lewis and Andrew Spiegel attended the 15th Annual Business of Biosimilars Conference held at the Omni Park Hotel in Boston. On day one of the conference, John Lewis from ACRO moderated a panel titled “Looking at the Commercial Realities of the Biosimilar Market”. Topics discussed included […]
October 23, 2014
Launches discussion about the future of biosimilars in Italy Results from a survey of 470 European physicians conducted by the Alliance for Safe Biologic Medicines (ASBM) set the stage for a stakeholder meeting at the Italian Ministry of Health to discuss the future of biosimilars policy in Italy. The October 20th event, titled “Biosimilars in […]
October 17, 2014
Introduces Chairman Gewanter, shows support for BQ proposal Geneva – The Alliance for Safe Biologic Medicines (ASBM) presented at the World Health Organization’s (WHO) 59th International Nonproprietary Naming Stakeholders Session on Tuesday, October 14, 2014. This was the third time ASBM presented to the WHO but the first appearance for ASBM’s new chairman Dr. Harry […]
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
EuropaBio published a new Guide and a new Position Paper on Biosimilars in Europe. With these two documents, EuropaBio continues its contribution to the policy debate on key issues regarding biosimilars among European and national regulators, policy makers, physicians, other healthcare providers and patients. Read the paper here.
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 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.
