European group criticizes proposed WHO, FDA biosimilar naming schemes

A new biosimilar naming system has been proposed by the WHO (World Health Organization), which is seeking to stem the proliferation of different naming systems globally. The proposed biological qualifier (BQ) system​ would tag biosimilars with a random alphabetic code that would represent a biological active substance manufactured at a specific site.

Adoption of the BQ scheme, which is promoted by industry groups BIO and USP​, would be to complement the use of INNs (International Nonproprietary Names).

The US FDA, meanwhile, has yet to release guidance on biosimilar naming, but has approved one biosimilar so far – Sandoz’s Zarxio, which it gave the name filgrastim-sndz, and which the ECB raised particular concerns about.

Criticisms​

In a report​ given before the WHO on Monday, Joerg Windisch, Chair European Biosimilars Group (EBG) and Chief Science Officer, Sandoz Biopharmaceuticals, said: “The more elements physicians and pharmacists have to record, and the more complex these elements are, the higher the likelihood something will get left out​.”

The EBG instead proposes that an additional identifier for biosimilars is unnecessary given the number of identifiers available today, such as the trade name, the INN plus the company name, the national drug codes and lot numbers.

Traceability, adverse reaction reporting, and prescribing were all reasons cited by the WHO for adopting a new naming scheme, according to the EBG, though the group claims: “All of these needs can be better fulfilled either with a trade name or by the combination of the INN + company name​.”

The current WHO proposal to connect the BQ to the active substance manufacturing site is also called “problematic​” by the EBG as it disconnects “the product from the company legally responsible for its safety - the market authorization holder​,” and it does not capture “the finished product manufacturing facilities, distribution, storage etc. and is redundant because the lot number already provides this information​.”

In addition, the EBG claims that the introduction of “a special system for a specific class of products disrupts this well-working unified system​.”

Biosimilar developer Hospira also seems to agree with the EBG on some parts of its presentation. Lisa Skeens, global VP for regulatory affairs, told BioPharma-Reporter.com: “We feel strongly that biosimilars should have the same INN as their reference product and that the FDA should adopt the EMA naming convention for biosimilars: Brand Name + Same INN​.” 

Sandoz’s Windisch added: “It would already be confusing enough to introduce an identifier just for biologics, and not for all other drugs… It would be even more confusing, and discriminatory, if an identifier were introduced only for products which go through a specific regulatory pathway. The premise of regulators is that the approval process for a biosimilar provides just as much reassurance as that for a novel biologic, only using a different, reference-based approach​.”

Other questions that EBG says the WHO has yet to address include: “How would the random sequences be generated? How would BQs be tested to ensure safety? Would the same BQ apply to all products from the same site? How would the BQ database be set up?​”

The EBG also says it presented to Med-ERRS, an independent organization specializing in the testing of names for the potential for medication errors, the FDA’s name for its first biosimilar. Med-ERRS came to the conclusion that “the nonproprietary name filgrastim-sndz is vulnerable to error​,” due to the potential confusion with existing filgrastim products as well as potential misinterpretation of the suffix “sndz.”