Backgrounders
Backgrounder: Biosimilar Basics
Backgrounder: Product Labeling
Backgrounder: Biologic Naming
Naming News
Letters to FDA Praise Use of Distinguishable Biosimilar Naming, Urge Greater Label Transparency
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 that clinically important product information is absent from the label. Dr. Gewanter said it is essential that the FDA include clear, appropriate and specific product labeling so patients and their healthcare team can make the best and most informed therapeutic decisions possible.
Read more here.
ASBM Presents at 60th WHO Naming Meeting
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.
Read more here.
ASBM Commends FDA for Approval, Clear Naming of First Biosimilar
The Alliance for Safe Biologic Medicines today commended the U.S. Food and Drug Administration (FDA) on its approval of the first biosimilar to be available for sale in the U.S. market. Approval of Novartis’ Zarxio (filgrastim-sndz), biosimilar to Amgen’s Neupogen (filgrastim), was widely expected following the January recommendation by an FDA advisory panel that it be approved for all five indications for which the reference product is approved.
Read more here.
ASBM Presents at WHO Meeting on Naming
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 L. Gewanter.
Read more here.
ASBM Attends WHO INN Stakeholders Open Session on Distinguishable Names
SBM was invited to share its perspectives before the World Health Organization’s 58th International Nonproprietary Names Consultation for Pharmaceutical Substances, Open Session for Stakeholders. At the meeting, ASBM Chairman Richard Dolinar, M.D., shared the results of a recent ASBM survey of European Physicians that concludes using the same INN for different biologic medicines can be misinterpreted by doctors and thus have unintended consequences for patients.
Read more here.
ASBM Presents New European Survey Findings on Biosimilars and the Importance of Nonproprietary Naming
The Alliance for Safe Biologic Medicines (ASBM) today released the results of a new survey on European physicians’ views on biosimilar naming. ASBM Executive Director Michael Reilly presented the findings at the Drug Information Association (DIA) Biosimilars Workshop in Dublin, Ireland. The key findings showed that nonproprietary names matter to patient safety.
Read more here.
Dolinar Authors Second Letter to WHO on Naming
ASBM Chairman Richard Dolinar, M.D., submitted a letter on July 31, 2013, to Dr. Margaret Chan, World Health Organization Director-General to reiterate ASBM’s position on the importance of using distinct non-proprietary names to ensure patient safety. The letter was sent to Dr. Chan and to the INN Expert Group, Department of Essential Medicines & Health Products, and the Health Systems & Innovation Division at the WHO in advance of their upcoming 57th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances to be held in Geneva on October 22, 2013.
Read full letter here.
ASBM Letter to WHO on Naming
On April 15-17, the World Health Organization (WHO) will hold the 56th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances. ASBM sent in the below letter advocating that all biologics should receive distinct non-proprietary names. We believe that the non-proprietary name of a reference product and product/s biosimilar to it should have a common, shared root but have distinct and differentiating suffixes. Instituting a system of unique names for biologic medicines will achieve the common goal of enhancing access to life-changing therapies, while also protecting the safety of the patients.
Read the letter here.
FDLI Publishes ASBM White Paper on Naming
The Food and Drug Law Institute (FDLI) Policy Forum published a white paper on biosimilar naming authored by the Alliance for Safe Biologic Medicines (ASBM). The white paper is titled, “It’s All About the Name: What is the Imperative of Adopting Unique Names For Biologic and Biosimilar Therapeutics?” and explains that biologic medicines are different from traditional chemical drugs, and present unique safety concerns to patients. Because of this fact the paper notes that in order to ensure patient-safety as biosimilars are approved in the U.S., they must be given unique, non-proprietary names.
Additionally, the white paper identifies key challenges and practical solutions to help facilitate a solution to ensure safety is the cornerstone of the biosimilars pathway in the U.S.
In the white paper, ASBM makes the following recommendations:
- All biologics should receive distinct non-proprietary names.
- United States Pharmacopeia (USP) should work with FDA to adapt the product monograph system to accommodate the unique attributes of structurally-related, but distinct, biologic medicines.
- The non-proprietary name of a reference product and product/s biosimilar to it should have a common, shared root but have distinct and differentiating suffixes.
- Products designated interchangeable should have a distinct name from the reference product for which they are considered interchangeable to facilitate accurate attribution of adverse events.
Read the paper here.
Letters to FDA on Naming
As the topic of naming gains traction, ASBM members have submitted letters to the FDA on the need for unique names to ensure patient-safety.
