Pharmacies, Labor Unions, State Retirement Systems, Payors Call on FDA to Protect Patient Safety and Patient Access by Preserving Accepted International Nonproprietary Name (INN) Conventions for Biosi



WASHINGTON, DC (July 1, 2014) —Today, 32 organizations 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.”

The full list of signatories to the FDA letter includes:

Academy of Managed Care Pharmacy (AMCP)

American Federation of Labor and Congress of Industrial Organizations (AFL-CIO)

American Federation of State, County and Municipal Employees (AFSCME)

American Foreign Service Protective Association (AFSPA)

America’s Health Insurance Plans (AHIP)

California Public Employees Retirement System (CalPERS)

Communications Workers of America (CWA)

CVS Caremark

Employees Retirement System of Texas

Express Scripts

International Union, United Automobile, Aerospace & Agricultural Implement Workers of America, UAW

J.B. Hunt Transport, Inc.

Kentucky Teachers Retirement System

Know Your Rx Coalition (Kentucky)

MetLife, Inc.

Military Officers Association of America

Missoula County, Montana

National Association of Chain Drug Stores (NACDS)

National Coalition on Health Care (NCHC)

Ohio Public Employees Retirement System (OPERS)

Pharmaceutical Care Management Association (PCMA)

Portico Benefit Services

Premier, Inc.

Prime Therapeutics

Public Sector HealthCare Roundtable

School Employees Retirement System of Ohio (SERS Ohio)

State Health Plan of North Carolina

State Teachers Retirement System of Ohio (STRS Ohio)

UAW Retiree Medical Benefits Trust

U.S. Public Interest Research Group (USPIRG)


West Virginia Public Employees Insurance Agency

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