FDLI Publishes ASBM White Paper on biosimilars naming

November 29, 2012 6:05 AM

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.
The paper also criticizes the situation in the EU:

In the EU, most biosimilars approved to date have the same INN as the reference product, which has created challenges for tracking and tracing biologics in Europe. In the case of epoetin alpha, the EMA subsequently required that all prescribers record the brand name in addition to the INN so as to ensure traceability going forward.
However, what the EMA giveth on one hand, the EU member state authorities are in the process of taking away. Specifically, a number of countries in Europe are requiring physicians to prescribe by INN and prohibiting the inclusion of a brand name, thus making accurate tracing of biologics in the event of an adverse event impossible. This situation could have been avoided if the EU had implemented a system in which biosimilars were required to hold a distinct INN.

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, innovative medical biotechnology companies, and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion. They serve as an authoritative resource center of information for the public, medical communities, the FDA and other state and federal policymakers during the implementation of the biosimilars pathway and beyond.

You can read the full paper here.


Source: ASBM press release

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