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Naming

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:

  1. All biologics should receive distinct non-proprietary names.
  2. 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.
  3. 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.
  4. 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.

AAPD Letter

Alliance for Patient Access Letter

ASBM Letter

Colon Cancer Letter

Health HIV Letter

RetireSafe Letter