European health officials have been much more open to biosimilars than their counterparts in the United States. Biosimilars approved in the EU “can be used for all their registered indications as safely as their originators and with no negative impact on therapeutic efficacy,” according to a recent study in Reumatologia.
Polish researchers argue that biosimilarity depends on comparability, which is used to highlight the similarity of a drug before and after a manufacturing change. European officials consider biosimilarity and reference products as different versions of the same substance.
The study does include some caveats. Researchers say there’s little evidence about the safety of multiple switches to biosimilars and that patients undergoing such switching should be closely monitored. They also call for long-term monitoring of such patients.
Researchers also stress the importance of clearly identifying in medical records the kind of medicinal product used. After being introduced to the market, all new biologics, including biosimilars, are closely monitored, according to EU legislation. Particular attention is given to reporting any suspected adverse events.
Whereas the United States has a strict definition of biosimilar interchangeability in accordance with federal law, in Europe interchangeability refers to the possibility of exchanging one product for another that is expected to produce the same clinical effect. Interchangeability in Europe is not regulated by the European Medicines Agency (EMA), Europe’s version of the FDA, but rather by individual European member states.
Source: The Center for Biosimilars, September 25, 2018