Thirty-two organizations have signed a letter calling on FDA to require biologics and biosimilars to have the same International Nonproprietary Name (INN), a practice currently in use in Europe and other markets.
"These groups understand that the INN approach to biosimilar naming has proven safe and effective in Europe, it has worked in the United States for chemical drugs and currently approved biologics, therefore it should be the standard for U.S. biosimilars, said Ralph G. Neas, President and CEO of the Generic Pharmaceutical Association. "The organizations who know the most about healthcare delivery agree: departing from the currently accepted INN system will not benefit patients," said Neas. "Instead, it will upset the very systems needed to accurately dispense and track medicines, risking increased mistakes and provider confusion."
As the letter states, "While we agree that it is important to gather data that allows providers to better understand how biologics and biosimilars are performing among various patient groups and to assist in the tracking of adverse events, as we mention above, we believe that the current mechanisms in place (e.g., NDC code, lot number, brand name, manufacturer, etc.) are sufficient. In addition, because adverse events and product recalls for small-molecule and biologic drugs already are successfully identified using the national drug code (NDC code) and lot number, there is no compelling evidence that biosimilars should be handled differently."
"American patients deserve access to safe, cost-effective biosimilars," said Steve Miller, M.D., Senior Vice President and Chief Medical Officer, Express Scripts. "By introducing just 11 biosimilars, we can reduce our nation's medical bill by $250 billion over 10 years, which would put important treatments within the reach of those who need them most. We're committed to working with all stakeholders to create a viable pathway for biosimilars in the U.S."
This letter follows concerns recently raised by the National Council for Prescription Drug Programs (NCPDP), citing serious operational problems with the implementation of a system other than the currently accepted INN construct. In a letter to the FDA, NCPDP cautioned about the impact such a change would have on the standard operating procedures inherent in the healthcare system. The standards-setting organization warned FDA that, "making changes to the current databases and the SOP's by which they are developed, maintained, and used takes time and resources. This can result in confusion, errors, and misunderstanding, resulting in a very real risk to patients, during any transition."
Neas noted that patient safety is of critical importance, stating, "The generic industry fully supports vigorous efforts to ensure these products continue to be fully identifiable as they move through the supply chain to the prescriber and the patient. To protect patient safety, the FDA should maintain the INN system for naming medicines, and apply it to biosimilars."