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 7, 2015
WHO Meetings in Geneva 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 April 13 in Geneva. The two provided perspectives from both a physician and pharmacist viewpoint and offered support […]
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 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 7, 2015
Labeling Survey Released as FDA Makes First Approval On March 23, ASBM Executive Director Michael Reilly, presented at “The State of Autoimmune Disease: a National Summit” held at the National Press Club and hosted by the American Autoimmune Related Diseases Association. During his presentation, he released the findings from ASBM’s new biosimilar labeling survey that reveals […]
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 […]
March 26, 2015
DENVER (CBS4) – Much cheaper, life-saving drugs could become available this year. They are called biosimilars and are copycat versions of drugs for diseases like rheumatoid arthritis, breast cancer and psoriasis. A bill before Colorado lawmakers would let pharmacists substitute the biosimilars for brand name drugs. The medications are different from the generics that have […]
March 26, 2015
Colorado’s biosimilars bill letting pharmacists provide patients with generic drugs in place of name-brand biotech medicines now needs only a governor’s signature to become law. The state House of Representatives passed the bill with only one ‘no’ vote on Tuesday, and it heads on to John Hickenlooper desk. Read more here.
March 23, 2015
Timely survey released as FDA approves first biosimilar The Alliance for Safe Biologic Medicines today released the results from a survey on physicians’ priorities related to biosimilar labeling. ASBM first shared the key survey findings at the “The State of Autoimmune Disease: a National Summit” held at the National Press Club and hosted by the American […]
