Issue link: https://www.e-digitaleditions.com/i/1118782
48 Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING 2019 P h a r mTe c h . c o m Biosimilars surveillance is primarily the reliance on sponta- neous reports from healthcare workers such as physicians or pharmacists. Passive reporting sys- tems for adverse drug reactions exist in Europe (EudraVigilance, EMA) (16) and in the US (Med- Watch, FDA) (17). Active surveillance generally involves examination of databases or patient registries to identify potential adverse events. In both cases, one of the keys to the success of a pharmacovigilance program is to be able to dif- ferentiate between similar products produced by different manufacturers (e.g., biosimilars). This has focused attention on the naming conventions that are used to distinguish these products in clinical practice. Naming conventions While in Europe the convention is to use brand names to identify and differentiate products, the situation in the US is quite different. There has been much debate over the preferred method of naming biosimilars in order to both facilitate ef- fective pharmacovigilance and also to encourage the adoption of biosimilars to control costs and improve patient access. Some organizations in the US advocated for the reference product and the biosimilar to share the same US Adopted Name (USAN). The argument was that this would facili- tate the adoption of biosimilars and would pro- vide some confidence that the products were in fact expected to produce the same clinical effects. However, in the US there is a high reliance on the use of the USAN and not on brand names in elec- tronic systems. Many argued that sharing a com- mon USAN would not facilitate accurate and effec- tive pharmacovigilance. In order for spontaneous reporting systems and active surveillance systems to be effective, there must be a reliable means of correctly identifying the specific product that the patient received. To assure pharmacovigilance and also in an at- tempt to avoid any perception of superiority or inferiority of the reference product and biosimi- lars, FDA has proposed a naming convention that entails assigning a unique suffix to every biologi- cal product. Biologics of the same therapeutic type would share a common "core name", but biosimi- lars would have a unique four-character suffix that is "devoid of meaning" or reference to the manu- facturer (18). The use of a suffix was preferred be- cause it would still allow products with the same core name to be grouped together in electronic da- tabases and systems for ordering, dispensing, and administering medicines. There has been concern raised about this ap- proach by FDA. One concern is that the use of distinct names will create the impression that the products may not produce the same clinical effects in patients (19). The second concern is around the use of a suffix that is "devoid of meaning". The use of a "non-memorable" suffix is expected to make it difficult for patients and healthcare workers to be clear about which specific products that patients are receiving, thereby benefiting the originators. Confusion or ambiguity in the communication of the specific product could lead to inadvertent switching and could actually harm overall phar- macovigilance efforts. One approach to reduce the likelihood of wrong product selection errors in the US would be to include brand names as well as the USAN for biologics into electronic systems and when communicating with patients, as is the case in Europe where the brand name is used as the unique identifier.