Earlier this fall, FDA issued a draft guidance proposing a middle-road approach to naming biosimilars. Unlike small-molecule drugs, where the branded and generic drug share the same nonproprietary name (also referred to as a proper name), the FDA proposed using the nonproprietary name of the originator product along with a distinct four-letter suffix “devoid of meaning” for originator products and biosimilars. FDA explained that distinct names were critical to ensuring patient safety and to minimizing inadvertent substitution of products that are not interchangeable. At the same time, FDA proposed a suffix consisting of four random lowercase letters so that it would be neither meaningful nor memorable. In this way, FDA intended to mitigate against concerns of biosimilar makers that distinct names would discourage adoption of biosimilars. FDA did not provide a proposal for naming interchangeable biological products. Instead, FDA requested input from the industry on the naming of such products in addition to seeking comments on its approach to naming biosimilars and their originator products.
Stakeholders’ comments are now in. FDA received comments from more than 170 groups. The comments largely fell into two camps. Innovator companies (including companies that also develop biosimilars), healthcare providers and patient advocacy groups favored distinct nonproprietary names for biosimilars. Biosimilar makers, insurers, pharmacies, and the Federal Trade Commission (FTC), by contrast, were largely in a different camp; they argued that distinguishable names are unnecessary for monitoring biosimilars and will likely bias providers against prescribing them. Notably, the two camps came together on the naming of interchangeable products. Since interchangeable products will likely first be approved as biosimilars, both camps advocated keeping the initial biosimilar name rather than changing it after approval as an interchangeable product. As a result of this unified view, FDA is likely to expand the naming approach it ultimately adopts for biosimilars to interchangeable products.
Innovator companies, physicians that prescribe biologics and patient advocacy groups praised FDA’s proposal to assign distinguishable nonproprietary names for biosimilars. For example, Bayer HealthCare, a company that develops originator biological products, stated that requiring distinguishable nonproprietary names “will help ensure patient safety, and potentially decrease errors in regards to pharmacovigilance, ordering, prescribing, dispensing, recordkeeping and insurance claims.” Genentech, a developer of originator antibody products, explained that “distinguishable non-proprietary names are in the best interest of patent safety, because they facilitate pharmacovigilance and mitigate inadvertent product substitution.” Similarly, Johnson & Johnson, an innovator company, stated that “a distinguishable nonproprietary name scheme is the best approach for ensuring optimal pharmacovigilance and safe use.” Johnson & Johnson explained that the use of “[d]istinguishable nonproprietary names will allow for sensitive and faster detection of, and response to, safety signals for a group of related biologics and individual or subsets of products within that group” and “also will guard against inadvertent switching of noninterchangeable biologics, which presents unnecessary and avoidable patient risk.”
Companies that develop both originator biologic and biosimilar products, such as Pfizer, Merck, and Amgen, also supported the use of distinguishable nonproprietary names. Allergan, another developer of biosimilar products, relied on its own prior experience with Botox to advocate for the use of distinguishable names for biologics. FDA assigned different proper names for Allergan’s Botox product and three other FDA-approved botulinum toxin products to avoid provider confusion and inadvertent substitution of the products.
Healthcare providers and patient advocacy groups also supported FDA’s use of distinguishable nonproprietary names. The Biologics Prescribers Collaborative (BPC) and professional organizations with biologics prescribers, such as the American College of Rheumatology, Alliance for Patient Access, American Association of Clinical Endocrinologists among others, applauded FDA for recognizing that “each biological product needs a distinguishable non-proprietary name.”
By contrast, a number of biosimilar makers, insurers, pharmacies and the FTC argued against the adoption of distinguishable nonproprietary names. Teva, a biosimilar maker, stated that distinct nonproprietary names are not necessary to avoid either the inadvertent substitution of noninterchangeable biological products or dosing errors. Similarly, Sandoz, the only biosimilar maker with an approved biosimilar in the US, said that “[i]ntroduction of suffixes to the non-proprietary names of biologics is not necessary and may even be problematic.” The Biosimilars Council of the Generic Pharmaceutical Association, which includes Sandoz and Teva among many other biosimilar makers as members, noted that a biosimilar product has other unique identifiers “including a brand name, company name, a lot number and a national drug code (NDC) number that readily distinguish it from other products that share the same [nonproprietary name].”
Teva and other biosimilar makers expressed concern that distinguishable nonproprietary names “may well undermine the goals of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) without advancing the principal objectives outlined in [FDA’s draft guidance].” Momenta stated that FDA’s naming policy would provide a “commercial marketing advantage” for innovators. Mylan said that “the proposed nonproprietary names will be misleading because distinct nonproprietary names generally communicate product differences and, in the case of biosimilars, will suggest that there are meaningful structural and clinical differences between biosimilars and their reference products”.
Blue Cross Blue Shield Association echoed the same concerns. It stated that distinct nonproprietary names for biosimilars would “create confusion for prescribers, pharmacists and patients, impeding on patient access to these cost saving medicines.” Similarly, CVS Health stated that FDA’s “draft guidance on the naming of biological products will undermine the goals of increasing biosimilar patient access and market competition.”
The FTC also viewed FDA’s proposal for naming biosimilars as a potential barrier to competition: “FDA’s proposal—to assign different suffixes to the drug substance names of biosimilars and their reference biologics—could result in physicians incorrectly believing that biosimilars’ drug substances differ in clinically meaningful ways from their reference biologics’ drug substances.” In FTC’s view this “could deter physicians from prescribing biosimilars, thus impeding the development of biosimilar markets and competition.”
FDA did not make a proposal for naming interchangeable biological products. Instead, FDA requested comments on what would be the potential benefits and challenges for an interchangeable product to share the same suffix as the originator biologic. Since most interchangeable products are first expected to be approved as biosimilar products, FDA also asked for comments as to the benefits or challenges of having to change the name of the biosimilar product that is subsequently determined to be interchangeable. Here, most stakeholders (including biosimilar makers) were uniformly of the view that it would be impractical and confusing to rename biosimilars that were later determined to be interchangeable products.
Teva, for example, stated that it “does not believe that the Agency should mandate name changes for previously licensed biosimilar products if and when they are deemed interchangeable.” It explained that “wholesalers and pharmacies will be made immediately aware of any change in a biological product’s status as soon as the Purple Book is updated, rendering a name change for the underlying product superfluous.” Sandoz emphasized that “[i]nterchangeable biosimilars must be allowed to keep the original suffix when first approved as a biosimilar. Given that the Purple Book will be the definitive source of status as a biosimilar or an interchangeable biologic, the suffix of an interchangeable biologic does not need to match that of the respective reference product.” Merck, Pfizer, Amgen and Allergan also agreed that interchangeable products should retain distinguishable nonproprietary names and should not have the nonproprietary name of the originator product. Similarly, Blue Cross Blue Shield stated that “[h]aving a product undergo a complete name change when it gets an interchangeable status is suboptimal. The change would impact product labeling, cause confusion for physicians, pharmacists, and patients, and will add inefficiencies into an already complex system.” As a result of stakeholders’ largely unified view on the naming of interchangeable biologics, FDA’s approach to the naming of biosimilar and interchangeable products is likely to be the same.