April 2015 Newsletter
May 7, 2015
|
Pharmacist Letter to FDA on Labeling
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 labeling. Jordan is former president of the American Pharmacist Association (APhA) and Schneider is a former president of the American Society of Health System Pharmacists (ASHP) and together the three pharmacists urged the FDA to consider a requirement for more informative labeling of biosimilars.
Read the letter here.
GaBI: Physicians’ views on biosimilars labelling
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 patients’ [1].
The survey, which was carried out prior to the first biosimilar approval, questioned 400 US physicians about what they expected and wanted to see when it comes to biosimilars labelling. Specialists in dermatology, endocrinology, oncology, nephrology, neurology and rheumatology were included in the research, which was carried out via a web-based survey.
Read the full article here.
GaBI: Physicians’ views on biosimilars labelling
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 patients’ [1].
The survey, which was carried out prior to the first biosimilar approval, questioned 400 US physicians about what they expected and wanted to see when it comes to biosimilars labelling. Specialists in dermatology, endocrinology, oncology, nephrology, neurology and rheumatology were included in the research, which was carried out via a web-based survey.
Read the full article here.
ASBM Presents at 60th WHO Naming Meeting
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 viewpoint and offered support for the WHO’s Biological Qualifier (BQ) proposal.
This stakeholder session was the second time Dr. Gewanter was given the privilege to present and it was ASBM’s fourth time attending. ASBM was especially pleased that Dr. Schneider presented with Dr. Gewanter and was able to provide a pharmacist’s view on the topic of naming.
“We are so grateful for the opportunity to present at the WHO,” said Dr. Gewanter in his opening remarks. “Biosimilars’ high sensitivity to manufacturing differences, light, heat, denaturing; and their potential to stimulate unwanted immune reactions, means clear product identification is essential. ASBM believes that information, cooperation, communication and collaboration are vital to ensuring the best outcomes for patients across the globe. Implementing the WHO’s BQ proposal will make patient safety a priority.”
Dr. Schneider agreed that the BQ proposal would help ensure safety through clear product identification.
“All medicines, regardless of their similarity, should be easily identifiable,” said Dr. Schneider. “The pharmacy community has long advocated that drug names be clear to help avoid confusion and errors – and this could not be more true when it comes to highly complex biologic medicines. They must be easily distinguishable from each other and from other medicines. It is our hope that regulators around the world, including the FDA and EMA, adopt the BQ proposal by the WHO INN Programme, and its application within their jurisdictions.”
ASBM has been very supportive of the WHO’s draft BQ proposal that would assign a four-letter alphabetic code to all biologics. In September of last year, ASBM and 14 of its member groups submitted comments to the WHO supporting the BQ proposal because it ensures clear product identification and promotes manufacturer accountability.
About the Alliance for Safe Biologic Medicines
The Alliance for Safe Biologic Medicines (ASBM) is an organization composed of diverse healthcare groups and individuals from patients to physicians, biotechnology companies that develop innovative and biosimilar medicines and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion.
For more information, please contact:
Michael Reilly
Executive Director
Alliance for Safe Biologic Medicines
Phone: 202-222-8326
Email: Michael@safebiologics.org
Podcast on FDA Biosimilar Approval
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.
March 2015 Newsletter
April 7, 2015
|
The Pew Charitable Trusts: More States Demand Notification to Use Biosimilar Drugs
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 thanks to Cimzia, one of a highly complex, usually expensive class of drugs known as biologics that derive from living organisms. Cimzia is recommended for women, like Crow, who are trying to get pregnant.
Read full article here.
The Pew Charitable Trusts: More States Demand Notification to Use Biosimilar Drugs
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 thanks to Cimzia, one of a highly complex, usually expensive class of drugs known as biologics that derive from living organisms. Cimzia is recommended for women, like Crow, who are trying to get pregnant.
Read full article here.
State Lawmakers Weigh Issue Of ‘Biosimilars’ — New, Life-Saving Drugs
March 26, 2015
