15 years of biosimilars

15 years ago this week the first ever biosimilar was approved in the EU. This was also the first approval worldwide for such a medicine.

Biological medicines have transformed the outlook for patients with many chronic conditions. Biosimilar medicines, which highly similar in all essential aspects to an already approved biological medicine, are expected to help increase access of patients to these medicines at an affordable price.

The EU has not only pioneered the regulation of biosimilars, we also have the highest number authorised of biosimilars worldwide. By the end of March 2021, we had, 65 valid marketing authorisations, corresponding to 16 different biological substances. We have reviewed 102 marketing authorisation applications for biosimilars, and given79 positive opinions. Nine more medicines are currently under review and there is an active pipeline of new developments for which EMA regularly receives requests for scientific advice.

We have learnt a lot over the years about assessing and approving biosimilars. The evidence from the clinical experience shows that biosimilars approved through EMA can be used as safely and effectively in all their approved indications as other biological medicines. We are confident after many years of use that biosimilars remain a safe and effective option.

Our knowledge is synthesized in scientific guidelines that help developers of biosimilar medicines to conform to the strict regulatory requirements. Scientific advice is available and used widely by developers.

Uptake of biosimilars across EU Member States is varied and misconceptions regarding the science behind biosimilars has been identified as one of the reasons for healthcare professionals and patients to shy away from using these medicines. Communication efforts have been a core part of the Agency’s role.

EMA and the European Commission developed an information guide for patients and an information guide for healthcare professionals. The input and collaboration of organisations representing patients, EU scientific experts and organisations representing doctors, nurses and pharmacists have turned these guides into reference documents that are used in the EU and beyond. A video for patients is also available. These materials explain in a clear, unbiased manner what biosimilar medicines are, how they are developed and approved in the EU and how EMA looks after their safety, and they are available in the 23 official EU languages.

EMA has been a trailblazer for biosimilars in the EU and the world. We have worked with international partners to contribute to the development of WHO guidance, offered trainings to other regulators and shared documents. 

The scientific knowledge and the clinical experience with the approved biosimilars accumulated over the years will drive the evolution of the regulation of these medicines, with the patients as the focus of all our efforts.