With the FDA expected to approve its first biosimilar within a year or two, how to name the follow-on biologics has passed from an academic debate to a must-do proposition. Since sponsors must include the name in the dossier when they submit a biosimilar application, those that are getting close to filing need to know pretty quickly how the drugs are to be named, Sumant Ramachandra, senior vice president and chief scientific officer at Hospira Inc., told BioWorld Today.

But until the FDA decides on biosimilar nomenclature, the debate will continue, as evidenced at Tuesday’s FTC biosimilar workshop, where naming concerns ranged from competitive advantage to ease of tracking adverse events. (See BioWorld Today, Feb. 5, 2014.)

What wasn’t up for debate at the workshop was industry confidence in the drugs the FDA will approve as biosimilars. “FDA-approved biosimilars will be among the most deeply analyzed and predictable” follow-ons to hit the market, said Emily Shacter, a consultant and former FDA biologics reviewer. Everyone at the table agreed with her.

The challenge now is to win the confidence of the public. How biosimilars are named is critical to that mission.

While following the science will lead to follow-ons that are highly similar to the reference biologic, “the science is not enough” when it comes to public opinion, said Aaron Kesselheim, an assistant professor of medicine at Brigham and Women’s Hospital and Harvard Medical School. The wrong naming scheme could suggest biosimilars are inferior products, he noted.

The World Health Organization’s (WHO) expert group that’s working on this issue is considering shared international nonproprietary names (INNs) with a randomized, global biological qualifier that would be unique for every biologic – be it an innovative drug, biosimilar or interchangeable. (See BioWorld Today, Jan. 28, 2014.)

How such ideas play with individual biosimilar sponsors depends in large part on the company’s business model. Amgen Inc., of Thousand Oaks, Calif., supports the proposed WHO scheme as it would make each biologic distinguishable worldwide. (Besides being a pioneer of innovative biologics, Amgen has six biosimilars under development through a partnership with generics giant Actavis Inc.; three are in pivotal trials.)

In addition to creating a level playing field, the proposal would give countries the flexibility to establish the unique qualifiers as either a prefix or a suffix to the INN, Geoffrey Eich, executive director of R&D policy at Amgen, told BioWorld Today.

Having a unique name would enable better pharmacovigilance, as it would facilitate linking adverse events (AEs) to their root cause, he said. This is especially important with biologics, which are sensitive to even minor changes in manufacturing and handling.

For instance, if a lot of a biologic was left on a shipping dock too long and the temperature changed its efficacy, the right naming scheme would help regulators track the problem, Eich said. But if there was no way to distinguish whether a patient received the innovator drug or one of several biosimilars, it would be much more difficult to pinpoint the problem.

FOLLOW THE BRAND

Hospira Inc., which has extensive experience with both generics and biosimilars, agreed that pharmacovigilance is important. But unlike generics that often use only a shared nonproprietary name, most biosimilars on the market in other countries have a brand name that can be used for tracking AEs, Ramachandra said.

Using the brand name, the Lake Forest, Ill.-based company has been able to track more than 95 percent of AEs to its biosimilar Nivestim (filgrastim) and nearly 100 percent of AEs to Retacrit (epoetin zeta). Both drugs are EMA-approved biosimilars.

Having biosimilar brand names makes a common nonproprietary name necessary, Ramachandra said, as it is the only thing that signals similarity to patients, payers, pharmacists and physicians.

Hospira has experienced the consequences in the EU of having a distinct INN for Retacrit while other epoetin biosimilars share the INN of the reference biologic, Eprex (epoetin alfa, Janssen Cilag Pharmaceutical NV). Because of its different INN, Retacrit isn’t covered in Romania and has been excluded from tenders for epoetin alfa in Italy and Spain. Although Hospira has engaged in lengthy, expensive legal challenges, the biosimilar is still excluded in some regions in those countries.

While Hospira is adamant that biosimilars are not generics and should not be regulated or marketed as such, it recognizes that some generics companies will try to cling to that model for follow-on biologics. If sponsors want to use the generic naming model rather than developing brand names for their biosimilars, Ramachandra said the FDA could require a unique identifier or qualifier for those products.

NEXT STEPS

The comments made at Tuesday’s workshop, along with those submitted to the FTC by March 1, will be wrapped into a report the commission will submit to the FDA. That report will be considered along with all the other comments the FDA will eventually receive on any naming guidance or rule it releases, Peter Pitts, president of the Center for Medicine in the Public Interest and a former FDA official, told BioWorld Today.

Because of the time crunch and how long it could take for the WHO INN Expert Group to finalize its naming recommendation, Pitts expects the FDA to act unilaterally on a biosimilar naming structure.

The INN group noted at its last meeting that global acceptance, as well as global standards for biosimilar approvals, would be needed for its voluntary scheme to work. Regulators from Australia and Japan, which have or are developing unique identifiers for biosimilars, agreed to conform to a unified naming system.

The EMA representative wasn’t so quick to jump on board. With several biosimilars already on the market in the EU, multiple qualifiers could cause prescriber confusion about what a biosimilar actually is, the EMA regulator said.

As in many other areas of public health, global harmonization of biosimilar naming would be optimal, Pitts said, but it’s not pragmatic at this time.

In the end, the FDA will base its decision on what’s best for public health – not on commercial interests, Pitts said. “It isn’t a question of tactics or strategies trying to squash biosimilars in the womb,” he added, responding to some of the comments raised at the FTC workshop that suggested concerns about pharmacovigilance were simply an effort by brand companies to protect their market.

Editor’s Note: This is the second part of a two-part series based on the FTC’s workshop.