Biosimilars: The naming puzzle

Sir,

In 1953, World Health Organization established International Nonproprietary Names (INNs) to ensure the “clear identification, safe prescription and dispensing of medicines to patients and for communication and exchange of information among health professionals and scientist worldwide.” Recently, biosimilars naming seems to be a bone of contention due to innovator companies favoring different INNs for biosimilars than their brand counterparts.[1]

Biosimilars naming is under intense discussion, meanwhile few countries have already adopted the naming system as per their understanding such as EU accepts the same INN for biosimilars as innovators product. In Japan, a biosimilar's nonproprietary name is followed by a word “follow-on” and its brand name by a letter “BS”, while in Australia, a biosimilar INN follows a suffix starting with letters “sim” (to signify the word “similar”) and can end with any letters the biosimilar company chooses.[2] However, many developing countries are in the process of introducing draft guidance for biosimilars naming.

There are several concerns associated with naming of biosimilar's INN different from innovator's product. First, it might create confusion among doctors and patients regarding the clinical efficacy and mechanism of action of biosimilars. Second, it would be nearly impossible that countries already adopted biosimilars naming systems will follow an entirely new system. Third, interchangeability and substitution of biosimilars will demand precise discretion by health professionals as the slight mistake on their part might be life threatening under emergency conditions. Fourthly, naming differently the biosimilars having minor chemical differences will make the pharmacovigilance tedious and put a lot of pressure on the regulatory framework. The excessive regulation of biosimilars will abolish the associated market advantage. So, how to bell the cat without introducing extensive reformations?

The issue is not tough, rather requires a careful choice of an alternative available for developing nations. Firstly, like EU a biosimilar INN may be same as innovator's product. Secondly, it may be followed by either a prefix or suffix. Thirdly, a color strip of any color can be made mandatory on the label to signify a biosimilar. Fourthly, the brand name of biosimilar can be printed to show the brand name along with its mirror image simultaneously without disturbing the INN. Fifthly, a symbol may be adopted to signify a biosimilar product.

Biosimilars provide a cheaper alternative to innovator's product. Several countries already adopted biosimilar's INNs with a slight deviation from the innovator's product. The rest of the world needs to adopt either an existing naming system or find an empirical alternative that is simple, reliable and empirical solution, universally acceptable and easily regulated.

The views expressed here are personal and have NO relation with the official position in the Department of Biotechnology, Ministry of Science and Technology, New Delhi, India.