Biological medicines (or “biologics”) are innovative treatments that have transformed the lives of millions of patients with many disabling and life-threatening diseases1.
When patents expire on original-brand biologics, different pharmaceutical companies are allowed to make these medicines, which have become known as biosimilars. An approved biosimilar is expected to match the original-brand biologic in terms of safety and efficacy, based on advanced laboratory studies, pre-clinical testing and clinical trials in patients1,2 . Biosimilar medicines are approved by the same regulatory authorities and are manufactured following the same high quality standards as for existing biological medicines2,3 .
Depending on the approaches of different healthcare authorities, biosimilar medicines have the potential to contribute to solving challenges around access to medicines for patients, physicians and payers4.