Biosimilar medicines in the EU

If you go to your doctor today for a disease like arthritis, Crohn’s disease, or some cancers, chances are they will choose from a wide range of innovative medicines known as biologicals. But it wasn’t always like this. Not long ago, there were far fewer biologicals to choose from. Part of the change came in 2006 when the European Medicines Agency approved the first biosimilar A biosimilar is a biological medicine that is highly similar to an existing biological medicine and works in the same way. Biosimilars are facilitating patients’ access to much-needed treatments in Europe as they make biological medicines more affordable and accessible for patients. So, what’s the deal with biosimilars? And…aren’t they the same as generics? Well, no, not exactly Generics are copies of small simple molecules like your aspirin or ibuprofen Biosimilars, on the other hand, are versions of much larger biological molecules the kind of molecules with thousands of atoms that we find naturally in our bodies like hormones, antibodies and other proteins. And because there is natural variability in biologicals, even molecules of the same medicine can have small differences And that’s why biologicals can’t be copied like other medicines. At the European Medicines Agency we have developed a rigorous approach to check that biosmilars are indeed highly similar to the original biologicals and that they work just as well in patients. So, how do we do it? We compare molecules of the biosimilar with the molecules of the original biological medicine and make sure that there are no meaningful differences between them that would affect how they work in patients. We check data from tests in the laboratory and in humans and compare them to test results from the original medicine. We can rely on some clinical trial data from the original but always ask the company that has developed the biosimilar for new studies if needed. Once on the market, we monitor the safety of all medicines including biosimilars, continuosly to check there are no unexpected side effects. If needed, we can take action to protect patients at any time. And because of the work we’ve done over the years there are now more biosimilars available for patients in the European Union than anywhere else in the world. This means more biological treatments for patients who need them and more choices for you and your doctor. To find out more about biosimilars including the one you’re taking check our website.

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