Biological medicines (or “biologics”) are innovative treatments that play an important and increasingly large role in the targeted treatment of a number of life-threatening and disabling disorders, such as cancer or immune-mediated diseases.27
When the patents for original-brand biologics expire, different pharmaceutical companies are allowed to make these medicines, which have become known as biosimilars. A biosimilar matches the reference medicine in terms of its analytical and functional properties, pharmacokinetics, and pharmacodynamics, as well as clinical efficacy, safety, and immunogenicity, based on the results of a comprehensive comparability exercise1,6,8. When considering product and manufacturing process quality, health authorities apply the same high standards to all biological medicines, irrespective of whether they are reference biologics or biosimilars1.
With suitable approaches from different healthcare authorities, biosimilar medicines have the potential to contribute to solving challenges around access to medicines for patients, physicians and payers4.
Biosimilars – the results are the same
Think of an original-brand biologic and a biosimilar like an original key and another version that a locksmith makes. Both keys produce the same result, both will fit the same lock and open the same door, even if there are slight differences between the keys.