ASBM Presents at WHO Meeting on Naming in Geneva
Calls for Distinct Non-Proprietary Names to Ensure Patient Safety
Geneva, Switzerland – The Alliance for Safe Biologic Medicines (ASBM) today presented at the World Health Organization’s (WHO) 57th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances in Geneva, Switzerland. During his presentation, ASBM Chairman, Richard Dolinar, M.D., called for the use of distinct non-propriety names for biologic medicines so that it is clear which medicine or medicines a patient received. Said Dolinar, “It is essential to patient safety that adverse events can be accurately traced back to the correct product. Distinguishable non-proprietary names for biologic medicines make that more likely.”
For nearly three years, ASBM has been dedicated to ensuring that patient safety is at the forefront of biosimilar policy across the globe as regulatory bodies around the world approve biosimilars for use. ASBM has strongly advocated that all biologics be given distinct non-proprietary names to facilitate accurate attribution of adverse events. 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. This will enable regulators to hold manufacturers accountable for the quality of their medicines.
Because biologics are made using living cells, as opposed to traditional chemical drugs, they are highly sensitive to the manufacturing process, storage, handling, etc. and small changes in the medicine can have important implications for patients. ASBM believes that the laws governing their approval and regulation must address that scientific reality in order to ensure patient safety.
In his presentation, Dr. Dolinar, a practicing endocrinologist, thanked the WHO for seeking input from the physician and patient communities and urged regulators worldwide to give biosimilars distinguishable names.
“We are grateful for the continued opportunities the WHO has given stakeholders like us to provide input as biosimilar policies are developed,” said Dr. Dolinar. “Product names are a foundational element of communication among health care providers and will have implications for the safe use of biologic medicines. When we speak about drugs, we need to be very specific. If a patient has an adverse reaction, which can occur months after receiving a biologic medicine, we need to be able to properly identify that medication. Instituting a system of distinguishable names will achieve the common goal of enhancing access to these life-changing therapies, while also protecting the safety of the patients.”
In advance of the WHO meeting, ASBM wrote two letters to WHO regarding the need for instituting a system of distinguishable names.
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. Visit us at www.SafeBiologics.org.
For more information, please contact:
Alliance for Safe Biologic Medicines