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Naming of Biosimilars


The International Nonproprietary Name (INN) is the official generic name given to a pharmaceutical’s active ingredient by the World Health Organization (WHO), and it applies to each product globally. Thus, products with the same active ingredient have always shared the same INN, even in different countries. The same name applies to the generic to a given brand medicines, but also to multiple independently developed brand biologics, as well as to biosimilars approved in Europe and elsewhere. Consistency, patient safety and sound scientific principles necessitate biosimilars having the same INN as their specific reference product, which is a brand product with the same active ingredient. Brand firms do not change names after post-approval manufacturing changes, even though the ‘changed’ product is NOT identical to its original. There is no evidence that a unique INN will improve the effectiveness of pharmacoviligance. The WHO’s INN naming system should not be changed without a good reason, and then the changes should be applied to all products for that same reason.

FACT: There is no legal basis for new INNs for biosimilars

Naming was not addressed in the Biologics Price Competition and Innovation Act (BPCIA), meaning the law does not require biosimilars to have a new name. Congress intentionally did not require biosimilars to have a new name, given that this issue was discussed when the legislation was being written. Biosimilar nomenclature should be established by the U.S. Pharmacopeial Convention (USP) and United States Adopted Names (USAN) just as it is for all drugs and biologics. Naming should be based on firm scientific principles – the same principles that apply to pharmaceuticals on the market today. For the vast majority of medicines the USAN matches the INN.

FACT: The WHO INN Expert Group recommended that no new process should be introduced for the naming of biosimilars

The WHO INN Expert group recommended that the current INN system should be maintained so that physicians and regulatory authorities around the world will be familiar with the active ingredients in all medicines. The current system gives the same INN to different products from different manufacturers even if there were slight differences. Thus, a biosimilar that is designed to be chemically and pharmacologically identical to the reference product should not have a different INN. A different INN for biosimilars would disregard important knowledge and safety information for prescribers. Given that there are no safety problems in various geographic regions in which biosimilars are marketed using the same INN, no new process should be introduced for the naming of biosimilars.

FACT: FDA assignment of unique INNs for biosimilars would cause confusion in a global marketplace

‘Biosimilar’ is a regulatory and legal term and is distinct from naming and the INN assignment process for biologics. Other highly regulated markets, such as Europe, have approved biosimilars with the name that matches that of their reference product because the active ingredient is the same. The WHO INN system for drugs and biologics has been in place since 1952 and is used by 197 countries. Any changes made should be carefully considered as the consequences will be worldwide.
In the United States, a drug’s USAN is usually the same as the INN. This is important as major biopharmaceutical companies manufacture for a global market. That global market already includes multiple approved biosimilars. The INNs assigned to biosimilars and already used in Europe, Japan, and other highly regulated markets match that of their reference. Biosimilars with different INNs in Europe and in the U.S. would cause confusion for physicians both within and outside the U.S. and make the collection of post-approval data and its analysis for adverse events associated with a given active ingredient much more difficult.

FACT: All biologics must be uniquely tracked but doing so would not be helped by a unique INN for biosimilars

The National Drug Code (NDC) is the most widely used and detailed system for tracking pharmaceuticals in the U.S. and provides much more information than an INN. The NDC contains information to uniquely identify the drug manufacturer and other information, including: drug strength; dosage form; formulation; and package size. NDC and lot numbers provide the most extensive information for tracking. The problems with tracking biologics or drugs will not be resolved with unique INNs for each biosimilar, as has been advanced by brand industry and brand industry supported groups. There is no supporting evidence that unique names will result in any better tracking, and there are credible arguments as to why it would be worse. One fundamental for any system to track the use of medicinal products is that complete records are kept – no system can compensate for the failure to record the necessary data.

FACT: Unique INNs for biosimilars might jeopardize safety

Unique INNs, were they to be imposed on biosimilars, would divorce the biosimilar from its shared regulatory history with the reference originator product on which its approval is fundamentally based. A biosimilar must have the same clinical pharmacology as the reference product, and by definition does not contain a new active ingredient. With a different INN, a prescribing physician may legitimately conclude that the active ingredients are different and so not recognize that the biosimilar and its related brand product have the same safety and efficacy history. Because of this, physicians may prescribe two highly similar products to the same patient because they have different INNs, yet treat the same medical conditions, resulting in double dosing. For safe prescribing, physicians would need to be knowledgeable of the INN for every biosimilar for each product, adding additional burdens on physicians and pharmacists to catch inappropriate treatment decisions.

FACT: Unique INNs Thwart Competition

Different INN names will make for a less competitive biologic marketplace, undermining a chief goal of the BPCIA. Not only will unique INNs create unnecessary confusion among health care providers and patients, states will not allow the substitution of a brand product with a biosimilar of the same ingredient if biosimilars have unique INNs. This is true even if FDA determines that a biosimilar can be substituted with the reference product. Lack of substitution, whether now or in the future, forces biosimilars to be marketed like branded products, increasing the costs of marketing a biosimilar and reducing savings to patients.