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Randi Hernandez was science editor at BioPharm International from September 2014 to May 2017.
Many European biosimilar groups argue that biological qualifiers should not be implemented in countries where the brand name or INN of a drug is already well established.
Industry stakeholders are meeting this week to discuss biological qualifiers (BQs) at the World Health Organization's (WHO) 59th International Nonproprietary Naming Stakeholders Session in Brussels. One of the main points of contention is the proper use of biological qualifiers for biologics.
The WHO plan suggests that BQs could be used for reimbursement purposes, prescribing, and substitution; however, groups such as the Biotechnology Industry Organization ask that BQs be used alongside of the international nonproprietary name (INN), in all circumstances where the INN is used. “BIO believes this should be facilitated by strongly encouraging national/regional regulatory authorities to include the BQ as part of the local nonproprietary name (i.e., for the United States, the United States Adopted Name or USAN),” comments the industry group. WHO does not have the regulatory authority to mandate a naming plan, according to InsideHealthPolicy.com.
Other groups have encouraged WHO to clarify exactly how the BQs would be used. “If the BQ is not part of the complete name, then it is less likely to be captured accurately in (pharmacovigilance) systems and products will not be identified accurately,” the European Biopharmaceutical Enterprises Association and European Federation of Pharmaceutical Industries said in comments to WHO, reports InsideHealthPolicy.com.
Joerg Windisch, MD, chief science officer at Sandoz Biopharmaceuticals and chair of the European Generic Medicines Associations (EGA)-European Biosimilars Group (EBG) said during the meeting that he supported the idea that the BQ would be voluntary, apply to all biological substances, and importantly, be applicable retrospectively. However, he noted that existing naming systems in Europe have worked well. EGA/EBG wrote in a summary of their position on BQs that “No additional component is needed in most jurisdictions as they manage very well with the brand name or INN accompanied company name; the BQ should NOT be implemented in these countries, including the EU since identification of biologicals is ensured and a number of legal tools and measures are in place. In any case, introducing a new identifier into the EU would require a legislative change.” The EGA Director General Adrian van der Hoven echoed this sentiment in a press release, saying, “Any new identification policy that discriminates against biosimilar medicines will limit patient access to biologics and also impact the realization of substantial cost savings for the EU healthcare systems.”
Unique product names, in addition to, and separate from, the active substance names (INNs), are the best solution to clearly identify a biologic product, to facilitate track and trace, and to avoid product ambiguity, noted Suzette Kox, senior director of scientific affairs at EGA and coordinator of European Biosimilars Group, in an email to BioPharm International. "We do not have the full picture of the situation in other WHO member countries but recommend that the BQ should only be used where it brings added value for clear identification," Kox wrote. "Furthermore, in countries like Japan and Australia, where a special naming system for biosimilars is in use, which hampers market access, switching to a BQ system for all biologicals in those markets could be beneficial and non-discriminatory."
Although WHO proposed that a BQ be linked to the manufacturing facility in which a drug product is prepared, Dr. Windisch expressed that the proposed BQ should not be linked to the active substance manufacturing site, but to the company which has marketing authorization of the product. This suggestion could create some pushback, as it would be more difficult to pinpoint where a manufacturing error may have occurred with just the drug marketing information.
Before biosimilars are subject to name modifications, Dr. Windisch suggests WHO should conduct research on the matter to see if using a 4-consonant code would confuse healthcare workers or lead to medication errors. “We suggest that the WHO INN Expert Group generates different options for the BQ, discusses them in a public workshop, and then has the different options user tested with all relevant stakeholders by an independent organization,” Dr. Windisch said in a release. “In the absence of such a study, a new system of identifiers cannot be supported and should not be implemented.”
In contrast, the Alliance for Safe Biologic Medicines (ASBM) supports WHO’s recommendation to assign a four-letter alphabetic code to all biologics. ASBM asserts that it backs the BQ proposal because “it ensures clear product identification and promotes manufacturer accountability.”