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WHO: Biosimilars Not the Same, Why Should Names Be?


By Mari Serebrov
Washington Editor

While names may not matter to a rose, the naming of biosimilars continues to be a thorny issue for regulators across the globe. And the World Health Organization (WHO) expects it to get a whole lot thornier over the next decade as biosimilar prescriptions begin to outnumber those for the original reference biologics.

Under the WHO's current international nonproprietary name (INN) policy, nonglycosylated biosimilars receive the same INN as the reference drug, as they're considered highly similar. But glycosylated biosimilars, considered comparable but distinct, get a qualifying Greek letter suffix – such as alpha or beta – added to the INN.

Looking toward the day when more biosimilars are on the market, the WHO sees two problems with its naming scheme. First, regulators are likely to run out of Greek letters for glycosylated biosimilars. And second, the use of identical INNs for other biosimilars could lead to inadvertent switching at the pharmacy.

As it is, not every country follows the WHO's naming policy, and there's confusion among those that do. In some cases, alternative interpretations of the policy have resulted in various regulators giving different INNs to the same biosimilar.

Wanting to nip those problems in the bud, the WHO considered uprooting its two-branched approach in favor of a naming system that would allow for distinguishable biosimilar INNs, according to recently released minutes from the organization's 55th consultation on INNs.

While the WHO's INN Group hasn't agreed on a proposal, it has pruned the idea of treating all biosimilars as unique products with unique INNs. That idea isn't viable, the group said, because it wouldn't fly with the biopharma industry.

Other options the group discussed included providing a biosimilar "identifier" that would be added to the INN as a suffix code for all biosimilars, glycosylated or not, or encouraging regulators to provide their own identifiers under WHO guidance. One possibility would be to add the brand name after the INN. That has been done in some countries but not consistently.

The naming was not limited to biosimilars. Some members of the INN Group thought scientific principles should drive naming, regardless of whether a biologic is approved as a biosimilar or a new drug. In other words, if an application is for the same compound, it should get the same INN.

The group was concerned that the FDA violated that principle in adopting modified INNs for me-too drugs approved as new biologics. Even though Zaltrap (ziv-aflibercept, Regeneron Pharmaceuticals Inc./Sanofi SA) and Tbo-filgrastim (Sicor Biotech) were approved as standalone biologics reviewed on their own merits without reference to another approved biologic, the FDA added a prefix to their INNs.

The naming of biosimilars continues to be a prickly subject in the U.S., where the FDA has yet to issue guidance. But the fact that the agency modified the INN for me-too standalone biologics may indicate that it's considering distinctive INNs for biosimilars.

The biopharma industry is sharply divided on the naming issue. Generic drugmakers that are getting into the market want biosimilars treated as generics, which means they would have the same INN as the reference product. But companies with extensive experience in developing biologics, such as Amgen Inc., think distinguishable names are necessary because no two biologics are expected to be identical.

"Hence there are no generic biologic medicines, and it is appropriate for naming rules to reflect this globally," the Thousand Oaks, Calif.-based company said in response to the WHO's consultation.

Distinguishable names for all biologics, including biosimilars, "will reduce the likelihood of inadvertent and inappropriate product switching and strengthen the accuracy of tracing via post-marketing safety monitoring systems," according to Amgen, which is developing six biosimilars through a partnership with Actavis Inc., formerly Watson Pharmaceuticals Inc. (See BioWorld Today, Dec. 21, 2011, Jan. 29, 2013, and Feb. 8, 2013.)

Another Sticky Point

Naming isn't the only sticky point for biosimilars in the U.S. As the Trans-Pacific Partnership Agreement enters a crucial phase of negotiations, Sens. Max Baucus (D-Mont.) and Orrin Hatch (R-Utah) are pushing the U.S. Trade Representative (USTR) to "aggressively protect" U.S. intellectual property rights, including the 12 years of data exclusivity for new biologics, in the trade talks.

Pharmaceutical Research and Manufacturers of America, which has long supported the inclusion of the 12-year exclusivity in all trade talks, applauded the senators' letter to the USTR. Strong intellectual property protections for biologics are critical to ensure the development of the next generation of medicines, the trade group said.

The senators' letter came on the heels of a declaration from a transatlantic coalition of consumer, public health and Internet freedom groups demanding that the European Union-U.S. negotiations of a Transatlantic Free Trade Agreement exclude "any provisions related to patents, copyright, trademarks, data protection, geographical indications or other forms" of intellectual property. (See BioWorld Today, March 20, 2013.)

Meanwhile, the Generics Pharmaceutical Association is urging Congress to reduce the data exclusivity from 12 years to seven years so biosimilars can enter the market sooner. (See BioWorld Today, March 14, 2013.)

Editor's note: For a copy of BioWorld's new biosimilars report, please contact the BioWorld Data account managers for exclusive introductory pricing at (800) 477-6307.