June 1, 2015
SAN DIEGO, CA- On May 28, 2015 a panel discussion was held that examined the perspectives of innovator companies, biosimilar manufacturers, biotechnology reporters, and the health provider community on the topic of biosimilar development and marketing. The panel was held in as part of the World Biosimilar Congress 2015. ASBM chairman Dr.Harry Gewanter provided the […]
May 21, 2015
WASHINGTON, DC- On Tuesday, May 19, 2015, ASBM met with Executive Branch officials to discuss the need for clear naming of biosimilars. In attendance were officials from the Administration’s Office of Management and Budget (OMB), its Office of Information and Regulatory Affairs (OIRA), the National Economic Council (NEC), and the Department of Health and Human […]
May 21, 2015
WASHINGTON, DC- On Tuesday, May 19, 2015, ASBM met with Executive Branch officials to discuss the need for clear naming of biosimilars. In attendance were officials from the Administration’s Office of Management and Budget (OMB), its Office of Information and Regulatory Affairs (OIRA), the National Economic Council (NEC), and the Department of Health and Human […]
May 13, 2015
On May 6, ASBM Chairman Harry Gewanter, M.D., sent a letter to Acting FDA Commissioner Stephen Ostroff, M.D, sharing ASBM’s recent survey on labeling and raising some concerns on the same issue. Dr. Gewanter pointed out that the labeling for the recently approved biosimilar, Zarxio, falls short with the FDA’s longstanding emphasis on transparency and […]
May 3, 2015
On April 23, Philip Schneider, University of Arizona College of Pharmacy professor, Ronald P. Jordan, Chapman University School of Pharmacy Dean and Joseph J. Bova, Director of Continuing Education at the Long Island University College of Pharmacy, sent a letter to Stephen Ostroff, M.D, Acting Commissioner of Food and Drug, on their concerns on biosimilar […]
April 20, 2015
On 23 March 2015, the Alliance for Safe Biologic Medicines (ASBM), which represents patients and physicians, as well as originator biological and biosimilars companies in the US, released results of a survey, which showed that physicians ‘support transparent, clear labels with data that enables prescribers to learn about and evaluate the medicines available to their […]
April 20, 2015
On 23 March 2015, the Alliance for Safe Biologic Medicines (ASBM), which represents patients and physicians, as well as originator biological and biosimilars companies in the US, released results of a survey, which showed that physicians ‘support transparent, clear labels with data that enables prescribers to learn about and evaluate the medicines available to their […]
April 14, 2015
Geneva, Switzerland – The Alliance for Safe Biologic Medicines (ASBM) Chairman Harry Gewanter, M.D. and International Advisory Board Chair and pharmacist, Philip J. Schneider, M.S., F.A.S.H.P., jointly presented at the World Health Organization’s (WHO) 60th International Nonproprietary Naming Stakeholders Session on Monday, April 13, 2015. The duo provided perspectives from both a physician and pharmacist […]
April 12, 2015
Nigel Rulewski, MD, Vice President of Global Strategic Drug Development and Head of Quintiles Global Biosimilars Unit, discusses the historic step the U.S. Food and Drug Administration (FDA) took on March 6, 2015 approving the first ever biosimilar product for the U.S. market. Listen to the podcast here.
April 5, 2015
Without the medicine Rachelle Crow takes for her rheumatoid arthritis, the 29-year-old Michigan woman’s face would frequently feel as if it were engulfed in flames. She would barely be able to crawl out of bed. She would have trouble opening or closing her fists or lifting her 3-year-old daughter. Crow can do all those things […]
