Biosimilars (biosimilar medicines) are copies of biopharmaceutical products for which the patent protection has expired. These medicines offer the same quality, safety and efficacy as the original products at a more affordable price, thus providing access of biological therapies to more patients.
Biosimilars are approved by regulatory authorities, such as EMA or FDA, following a stringent review process, ensuring equivalent quality, safety and efficacy as the reference product. Biosimilars help to treat many diseases, such as autoimmune diseases or cancer.
There is over 10 years of practical knowledge with biosimilars development and approval in Europe, with the first biosimilar approved in 2006. Since then, EU-approved biosimilar medicines have already generated more than 400 million patient days of clinical experience worldwide. Biosimilars are allowing for a broader use of biologics therapies, and they will further transform healthcare by increasing patient access and contributing to the sustainability of healthcare systems.
If you would like to learn more about biosimilars, you are welcome to contact us, and we will answer your questions. For further information, we have compiled some useful background information: