By: Laura Fuentes
(Source: EMA)
A biosimilar medicine is a biological medicine that is very similar to an authorized biological medicine and works in the same way.
Biosimilar products facilitate patient access to treatment by making biologic medicines more affordable and accessible to patients.
So what does biosimilar mean? Isn’t it the same as generic products? Not exactly, generic products are copies of simple and small molecules, biosimilars on the other hand are versions of much larger biological molecules, the kind of molecules with thousands of atoms that we naturally find in our body such as hormones, antibodies and other proteins; and since there is a natural variability in biologics and even molecules of the same drug, they can have small differences, and that is why biologics cannot be copied like other drugs.
How do regulatory agencies ensure that biosimilar products are optimal? They compare molecules from the biosimilar with molecules from the original biologic drug and make sure that there are no significant differences between them that could affect patients. In addition, laboratory and human test data are checked, compared with the test results of the original drug, and may also be based on some clinical trial data from the original, but if necessary new studies are always requested from the company that developed the biosimilar.
Once the product is on the market, they continuously monitor the safety of all drugs, including biosimilars, to check for unexpected side effects; and if necessary, they can take action at any time to protect patients.