Biosimilars Council Urges Regulatory Agencies to Use INNs for Biosimilars

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The GPhA-run organization asks regulatory agencies to keep international nonproprietary naming conventions intact for biosimilars.


The Biosimilars Council wrote a letter to FDA and the Department on Health and Human Services (HHS) on June 30, 2015 urging the agencies to identify and name biosimilars by their international nonproprietary names, rather than by distinguishable, unique names. The letter comes prior to the publication of a formal FDA guidance on biosimilar naming, which is due to be released at some point in 2015. The letter is similar to one that The Generic Pharmaceutical Association (GPhA) sent the FDA almost exactly one year ago.

The council argues that the current mechanisms used to identify drugs-such as the NDC code, lot number, manufacturer, and brand name information that is currently included in a drug’s packaging-are sufficient to allow for the proper tracking of a biosimilar. The council says that new naming procedures have the potential to interfere with current pharmacy safety alert systems that already successfully flag adverse events associated with biologics. In addition, the council asserts that any departure in naming could prevent patients from accessing life-saving medications as a result of payer and pharmacist confusion.

“We share the FDA's deep commitment to patient safety, and as such, we believe that biologics and biosimilars should be required to have the same International Nonproprietary Name (INN). Requiring different INNs for biologics and biosimilars could lead to patient and prescriber confusion, increasing the possibility of medication errors, and would also effectively separate the biosimilar from existing safety information about the underlying molecule,” stated the letter.

The World Health Organization has proposed the use of biological qualifiers (BQs) in addition to INNs to provide more information about where a biosimilar has been manufactured and to assist investigators in the tracing of problems when an adverse event has been reported. The BQ could also be used for reimbursement purposes, prescribing, and substitution, says WHO. While many groups seem to support the use of a BQ with an INN, there is no consensus on whether the BQ will be part of the complete name, or used in conjunction with, or alongside, the INN. If used as a part of the INN, some trade groups are concerned that the products will be less likely to be captured accurately in pharmacovigilance systems.


The Alliance for Safe Biologic Medicines (ASBM) supports WHO’s recommendation to assign a four-letter alphabetic code to all biologics. ASBM has said that it backs the BQ proposal because “it ensures clear product identification and promotes manufacturer accountability.”

The following organizations-comprised mostly of pharmacies, payers, and pharmacy benefits managers-signed the letter from the Biosimilars Council to FDA and HHS:

Academy of Managed Care Pharmacy (AMCP)
American Pharmacists Association (APhA)
America’s Health Insurance Plans (AHIP)
The Biosimilars Council
California Public Employees Retirement System (CalPERS)
Council for Citizens Against Government Waste
CVS Health
Express Scripts
Healthcare Supply Chain Association (HSCA)
National Association of Chain Drug Stores (NACDS)
National Coalition on Health Care (NCHC)
Ohio Public Employees Retirement System (OPERS)
Pharmaceutical Care Management Association (PCMA)
Premier healthcare alliance
Prime Therapeutics
Public Sector Health Care Roundtable
Rite Aid
UAW Retiree Medical Benefits Trust

Source: GPhA