The Need for Distinct Nomenclature for Originator and Biosimilar Products

Category: Review Article
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Abstract:
The arrival of biologic drugs has provided an important advancement in the treatment of complex diseases. However, the inherent complexities in developing and manufacturing biologics have inevitably meant that treatment with biologics is costly, which in turn places a high burden on the health-care system. In the United States (US), spending on biologics has increased from 13% of pharmaceutical spend in 2006 to 27% in 2016. [1] In 2007, the average daily cost of a biologic was 22 times the average daily cost of a small molecule drug. [2] Biosimilars have the possibility to lower these costs and to offer additional treatment options for patients.

The pace of biosimilar approvals in the United States has been accelerating, with FDA approving five products in 2017, two of which were for the blockbuster originator biologics Humira® and Remicade®. [3] Currently, there are 12 biosimilar products approved in the U.S. and 22 distinct biosimilar products approved in the EU . In fact, over the first 8 ½ years of the regulatory pathway being established, the FDA has approved more biosimilars to more reference products (12 unique biosimilars to 8 reference products) than the EU (5 unique biosimilars to two reference products). As the number of biosimilar approvals continues to grow, the collection of pharmacovigilance data that are accurate and attributable to the specific product will increase in importance. Different countries and regions have taken various approaches to ensuring accurate product traceability, with the EU electing to pass legislation requiring the recording of brand name, batch number, and lot number while the U.S. and Japan electing to pursue the use of distinguishable non-proprietary names. The latter has been criticized by some that believe it may negatively impact uptake of the biosimilars. There is, however, no evidence that this is the case.

The naming of biosimilars has become complex and inconsistent globally. The introduction of final guidance by the US FDA on the naming of biologics, including biosimilars and their reference products, with the addition of a distinct four-letter suffix to the non-proprietary name was a major step forward in providing a mechanism for more accurate pharmacovigilance. Those in favour of the suffix state that the distinct nomenclature allows for better product-specific tracking of safety and real-world effectiveness. This in turn promotes prescriber and patient comfort, enhancing a robust marketplace, and thus serving an important role in the overall adoption of biosimilars.

Those who argue against differential naming of biosimilars, including the Federal Trade Commission, state that it causes confusion for prescribers, as distinguishable non-proprietary names will make physicians believe there is a difference between the originator and the biosimilar. This, they suggest, would create an artificial barrier by discouraging prescribing, with the consequence of slowing uptake and the potential for cost savings.

In light of the recent FDA guidance on biosimilar naming and in response to a Federal Trade Commission statement on a recent Department of Health and Human Services Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Cost, we conducted a review of published evidence to demonstrate that the introduction of a distinct international non-proprietary name (INN) and a global naming standard for biosimilars would be beneficial.[4, 5].

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