FDA's proposal to include a four-letter suffix in the nonproprietary names of all biological and biosimilar products has garnered strong support from innovator biopharmaceutical firms. However, the agency's preference that the suffix be "devoid of meaning" appears to be facing near universal opposition from industry.

Instead, industry groups and individual companies generally favor suffixes that will be memorable and meaningful, preferably derived from a sponsor's name and available for use across a company's biologic product portfolio.

"The use of a memorable suffix unique to a license holder will provide a biological naming convention that reduces confusion and enables effective pharmacovigilance," the Biotechnology Industry Organization (BIO) said in recent comments to the agency. "This will also permit health care practitioners to associate the particular suffix of each biological product with the identity of that product."

A suffix linked to a company, rather than one specific to each product, will create fewer burdens for sponsors and FDA, industry commenters said.

Such an approach, industry commenters said, also will reduce the burdens on companies to develop, and on FDA to review, different suffixes for each product.

The comments respond to an August draft guidance in which FDA laid out its plans to distinguish most innovator biologics and biosimilars with a suffix added to the nonproprietary name ([A#14150827006]).

The agency's proposal to apply the naming convention retrospectively for existing products is largely supported by industry (see related story,[A#00151109003]).

Simultaneous with the guidance the agency issued a proposed rule that would implement the name change for six approved products; the comment deadline on the proposed rule is Nov. 12.

Split Within Industry

FDA asserts that adoption of a suffix-based nomenclature across biologic products would facilitate safe use by preventing inadvertent substitution, enhance product pharmacovigilance and avoid inaccurate perceptions about the safety and effectiveness of biological products based on their licensure pathway.

The guidance outlined a process for proposing a suffix, with the directive that the suffix should be four lower-case letters, unique and devoid of any meaning, The suffix should not be promotional, suggest any drug substance name or be too similar to another product's suffix ([A#14150827003]).

There remains a sharp divide within industry between those who support distinguishable proprietary names for biosimilars and reference products – a group that includes BIO, the Pharmaceutical Research and Manufacturers of America (PhRMA) and individual big pharmas, some with their own biosimilar development programs – and those strongly opposed to such an approach.

The latter category includes the Generic Pharmaceutical Association (GPhA), the group's Biosimilars Council, and some biosimilar developers that traditionally have focused on small molecule and complex generics, including Sandoz Inc., Apotex Inc., Teva Pharmaceutical Industries Ltd. and Momenta Pharmaceuticals Inc.

These entities assert that giving biosimilars a nonproprietary name different from that of the reference product will create confusion and uncertainty about the new category of products, hindering biosimilar product uptake and impeding competition.

Creating a new naming convention with unique International Nonproprietary Names "will instill uncertainty, compromise safety and limit ability to improve patient access to biologics," GPhA and the Biosimilars Council's comments state said. "Unique names could disrupt the current naming system and inhibit market creation for biosimilars."

Adding a suffix to the proper name is unnecessary and will lead to confusion among prescribers and patients, potentially resulting in medication errors and mistranscription in medical records, GPhA and the council assert.

GPhA finds support in its argument from the Federal Trade Commission; FTC's comments assert that distinguishable names will increase the likelihood of perceived product differentiation, hindering competition in the process.

Make It Memorable

Despite these objections, most of the biopharma companies who submitted public comments on the draft guidance favored FDA's approach on distinguishable naming (see graph).

While supportive of a suffix-based approach, many companies said it would be important for the suffix to be something that prescribers, pharmacists and patients could remember and associate with a particular product, as opposed to four random letters.

Memorability would help encourage consistent use of the naming convention in prescribing, dispensing, medical literature, advertising and promotion, adverse event reporting and recordkeeping, BIO's comments state.

"Even a random suffix may eventually acquire memorability through this process of use; however, it will be more difficult to achieve memorability with a random suffix, and less effective, than if the suffix was inherently memorable and meaningful."

Most of the industry commenters favored a suffix derived from the license holder's name, or that of the entity responsible for pharmacovigilance of the product.

This is the approach FDA took with the "placeholder" name it approved for the first biosimilar, Sandoz's Zarxio (filgrastim-sndz), which references Amgen Inc.'s Neupogen (filgrastim).

Assigning a meaningful suffix, such as one derived from a company's name, "most realistically accounts for the fact that these suffixes will be used by people (as opposed to just machines) – and people would benefit from an easy‐to‐use solution," Amgen's comments state.

"If the suffix is random and different for every product, we foresee complications, including a proliferation of meaningless identifiers that may confuse health care providers and patients."

Industry commenters say allowing each company to use the same meaningful suffix across its product line would be less burdensome for sponsors and FDA than assigning a unique suffix to each individual biological product. PhRMA's comments call on FDA to "create a streamlined process for license holders to propose their suffixes to reduce burdens on both the agency and industry."

Comments from the Biosimilars Forum , an organization of biosimilar product developers whose members include both Amgen and Sandoz, took no position on whether a suffix should be included in the nonproprietary name. However, the group said any suffix should be derived from the company name and used for all products developed by that sponsor.

There was strong support among commenters for allowing companies to use different suffixes in certain limited circumstances, such as when a manufacturer markets two versions of a product or a safety issue arises. In addition, sponsors should be able to request a suffix change in the event of a merger, acquisition or product divestiture, comments said.

Although Janssen Pharmaceutical Cos. said a company-based approach to suffixes would be acceptable, it acknowledged several potential downsides, including a change in license holder and difficulty in harmonizing names with other countries.

"We note that there are alternative approaches to memorable names that we would also support and would avoid some of these downsides," Janssen's comments state.

"For example, one might name a product filgrastim-filx, where fil is derived from the 'core' name and x represents a distinguishing number or letter indicating approval order (e.g., 1, 2, 3, or a, b, c) or pathway (i.e., new biologic, biosimilar, possibly interchangeability status). Alternatively in this approach, the first three letters could come from the name of the sponsor (e.g., filgrastim-sndx)."

Sandoz: Let Us Keep -Sndz

Sandoz, the only holder of an approved 351(k) application, takes the view that suffixes are not necessary for pharmacovigilance and could be problematic. However, if suffixes are required, they should be derived from the company's name (as was the case with its filgrastim-sndz) and shared by all biological products in a company's portfolio, the firm said.

Sandoz's comments challenge assertions that suffixes derived from the license holder's name could confer an unfair market advantage for certain companies.

"It is important to note that if all sponsors have a single suffix appended to the non-proprietary name for their products that is derived from their company name and is applied to all of their biosimilar products, any advantage or disadvantage will be applied equally to all," the Novartis AG subsidiary said. "Newer and perhaps smaller companies may obtain a level of recognition beyond what they had previously had.”

Sandoz suggested that FDA should conduct a study on memorability of random sequences if it stands by the current proposal for non-meaningful suffixes.

Momenta agreed with FDA's preference for a suffix devoid of meaning, even though the company does not believe that suffixes are warranted in the first place

FTC's comments also recommend that FDA test how prescribers will react to its proposed nomenclature changes before implementing them.

Momenta Pharmaceuticals was among the minority of industry commenters who agreed with FDA's preference for a suffix devoid of meaning, even though the company does not believe that suffixes are warranted in the first place.

"We still believe the best remedy would be to not use a suffix for all biologics and to have all biosimilars share the same proper name," Momenta's comments state. "If, however, a suffix will be used for all biologics then it should be a random set of characters that is assigned to each biologic manufacturer."

Treatment Of Interchangeables

Momenta also was in the minority view among industry commenters in saying that an interchangeable product should carry the same suffix as its reference product.

"Unique proper names would likely create a need to use sales and marketing communication to resolve the confusion" created by different names, Momenta said. "A significant incentive for companies to pursue the designation of interchangeability, however, is to allow for commercialization without sales and marketing communication. Thus, this kind of confusion could make investment in development for interchangeability uneconomic, and significantly reduce the opportunity for innovation and savings that might otherwise have been achieved."

BIO and other commenters observe that most interchangeable biological products are likely to be licensed first as biosimilars and, therefore, already would have a distinguishable suffix under FDA’s proposed naming convention.

"Changing the suffix of a biological product to that of its reference product upon a determination of interchangeability risks creating confusion among health care practitioners and undermining the agency’s stated objectives of ensuring the safe use of biological products and enhancing biological product pharmacovigilance," BIO said.

Sandoz, which is expected to pursue an interchangeability determination for Zarxio, also said that interchangeable biologics need not carry names that are identical to their reference product. Sandoz pointed to the additional costs and difficulties a biosimilar product sponsor would incur if it were required to change its suffix to match that of the reference product upon an interchangeability determination.

"Another option could be to impose yet a third new suffix on the interchangeable biologic and reference product," Sandoz said.

"Use of a third new suffix in order to burden both equally would be particularly unfortunate for all stakeholders. In addition, it would lead to the need to continuously change suffixes a third, fourth or perhaps even more often if multiple interchangeable biologics are approved to a single reference product. This possibility alone makes the 'third new suffix' concept impractical," Sandoz said.

FDA's Biologics Naming Plan: Industry Wants 'Memorable' Suffixes

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