HPE Viatris Handbook | Page 5

TABLE 1

Some examples of suffixes 12

-adbm -abtx -dkst -atto -jmdb -awwb -sndz -dyyb -epbx -abda -szzs -cbqv

• Differentiate the biosimilar from its RP

• Differentiate biosimilar A from biosimilar B , C , D , etc .

Currently this is handled on a country-by-country basis . The EU naming system clearly differentiates between product name and INN and is highly reliable . Evidence suggests that the system facilitates and guarantees reliable identification and robust product safety reporting . The general framework for naming of biologic and biotechnical products is published and updated by the WHO . 8

This nomenclature scheme has evolved over the years . Since the scheme was introduced , all pharmacological substances that contained an immunoglobulin variable domain have used the stem -mab ( e . g ., adalimumab , bevacizumab ). Given a large and growing number of names ending in -mab , devising new and distinct INNs has become a challenge . INNs must be sufficiently distinct from each other to minimise the risk of medication errors .

Moreover , the -mab stem was used for many different structures ranging from small immunoglobulin fragments to large molecules containing multiple antigen binding sites . The WHO INN Expert Group therefore decided to revise the system to ease this situation . The revised system was approved and adopted by the WHO at the 73rd INN Consultation held in October 2021 , and the decision was made to discontinue the use of the well-known stem -mab in naming new antibodybased drugs and , going forward , to replace it with the four stems : -tug , -bart , -mig , and -ment . 9 Broadly , the suffix -tug is for unmodified immunoglobulins , -bart is for artificial immunoglobulins , -ment is for immunoglobulin fragments and -mig is for multi-specific immunoglobulins . 10

FDA requirements In a further attempt to distinguish biosimilars from the RPs and from each other , the US Food and Drug Administration has developed a list of suffixes . A four-letter suffix that is unique , devoid of meaning , composed of four lower case letters ( of which three are distinct ), non-proprietary and free of legal barriers that would restrict its usage may be added to the non-proprietary names of all biosimilars , as well as to the nonproprietary names of all biologics approved after March 2020 . 11 Examples of some suffixes are shown in Table 1 Some reservations about the scheme have been expressed . The lack of memorability of the suffixes might undermine their value . Early reports suggested that when reports of adverse reactions to biosimilars were filed , the four-letter suffixes were almost always omitted . 13 This could simply be because health care professionals were not familiar with the new scheme and did not realise the significance of the suffixes .

Other territories The different approaches to naming and labelling of biosimilars used in different countries was investigated by the World Health Organization ( WHO ) in a survey in 2019 – 2020 . 14

The survey found that most of the countries did not have specific regulations / guidelines relating to the naming and labelling of biologics / biosimilars . Countries that do have specific regulations / guidelines include Canada , China and Japan among others . 14

In Japan , biosimilars are referred to by the non-proprietary name of the reference biologic , followed by BS to denote biosimilar , the respective follow-on number and an abbreviation to reference the manufacturer . 15

The naming criteria for biologics in China is fully implemented . The Chinese regulatory authority also prepared draft guidance on naming biosimilars in 2018 , but this has not yet been officially adopted . 16

Canada established its naming policy in 2019 in its Notice to Stakeholders – Policy Statement on the Naming of Biologic Drugs . In the guidance , it states that biological drugs , including biosimilars , will be identified by their unique brand name and non-proprietary ( common ) name , without the addition of a product-specific suffix . 17

Conclusion First introduced to the market in 2006 , biosimilars are considered a good alternative to innovative biologics . The potential exists for more biosimilars to become available over the next few years ; therefore , it is important for healthcare providers to understand the key issues surrounding biosimilars and their terminology , their development and approval and the nomenclature and naming conventions .