GHP Q1 2018

24 GHP / Q1 2018 , New Tool to Help Biologic Medicine Names Comply with Industry Standards An exciting newnaming tool for biologic medicines has been released which ensures compliance with FDA andWHO Standards. The Alliance for Safe Biologic Medicines (ASBM) has announced that it has developed a web-based tool for the naming of biologic medicines to quickly ensure compliance with naming standards set forth by the FDA and World Health Organization (WHO). The tool, called “SuffixAudit”, will be made available to regulators and manufacturers. Biologic medicines are complex molecules engineered to treat serious and chronic conditions including rheumatoid arthritis, psoriasis, and cancer. Lower-cost versions of these medicines, known as biosimilars, are becoming available but unlike generics, they are not exact copies of their reference product. These inherent differences have caused health regulators worldwide to make clear product identification a priority. “The distinct naming of all biologics, including biosimilars, allows regulators to accurately track products, ensure their continued safety and efficacy, and attribute any adverse events to the correct product”, said Michael Reilly, executive director of ASBM. To accomplish this, the FDA and WHO have each proposed a system which appends a distinct four-letter suffix to a root name shared by the innovator medicine and all biosimilars to that product. While similar, the FDA and WHO systems employ different sets of rules, including which letters may be used and how many unique letters must be used in a suffix. Both systems exclude suffixes that exhibit meaning (e.g. those that are too similar to company names, stock symbols, or words). ASBM’s SuffixAudit checks a proposed suffix against regularly-updated lists of words, stock symbols, medical and pharmaceutical terms, and combinations not in compliance with FDA or WHO rules. It can also encode suffixes with a 32-bit “checksum”, an additional mathematical safeguard against inadvertent substitution that is required by the WHO Biological Qualifier (BQ) system. “SuffixAudit allows a manufacturer or regulator to quickly test a potential suffix against the FDA established naming rules for biologics, the WHO’s proposed any potential conflicts or rule violations. “SuffixAudit represents the next generation in biologic naming compliance and will help to streamline the implementation of this approach in any region wishing to pursue distinguishable names. Manufacturers and regulators will be able to name biologics and biosimilars with confidence, ensuring clear product identification regardless of which of the two suffix systems is ultimately adopted as the global standard. ASBM looks forward to meeting with regulators in coming months to offer SuffixAudit as an aid to implementation of distinct naming and to international harmonization” said Mr. Reilly. BQ standard, or both, as regulators continue their work to harmonize naming globally”, said Jeff Jones, PhD; an ASBM Advisory Board member and chief architect of the tool. ASBM has worked closely with the WHO since 2013 in the development and implementation of the BQ system, including providing survey data which shows broad support for distinct naming among physicians worldwide. In April 2017, ASBM presented the WHO with a precursor to SuffixAudit called “SuffixDB” which empirically demonstrated the feasibility of implementing the four-letter suffix system by generating many thousands of BQ-compliant suffixes and reliably detecting