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 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 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 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.
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.
