In October 2019, the European Medicines Agency (EMA) released an information guide for healthcare professionals on biosimilar medicines (Biosimilars) in the European Union (EU)1.
The guide summarises what biosimilars are and why they are not considered to be generic medicines. It discusses how a robust regulatory framework and approvals process has been developed by the EMA and considers biosimilar safety and efficacy.
For healthcare professionals and prescribers, the guide explains interchangeability and substitution practices in the EU. In the context of biosimilars and reference medicines, it refers to the practice of exchanging one medicine for another medicine which is expected to have the same clinical effect. It also describes how to communicate with patients about biosimilars and signposts to a question and answers document written in patient-friendly language on the European Commission’s website2. The use of biosimilars is becoming more and more prevalent.
For Industry – the guide highlights the implications of the availability of biosimilars. Biosimilars introduced to the market are usually competitively priced compared to the reference medicine as biosimilars can be developed without costly unnecessary repetition of clinical and non-clinical studies.
The EU has been a pioneer in biosimilar regulation. The first biosimilar was approved in the EU in 2006 and since then, the strong regulatory framework developed by the EMA has shaped biosimilar development globally. The Therapeutic Goods Administration (TGA) in Australia directly applies the principles set out in the EU legislation for the development and approval of biosimilars. Australia approved its first biosimilar in 2010 and adoption continues apace. In the first half of 2019 the TGA approved 3 new biosimilar medicines. The Food and Drug Administration (FDA) bases its regulatory requirements on the EU model and in 2014 approved the first biosimilar in the US.
To take advantage of our expertise in Biosimilars, from Regulatory Strategy through to commercialisation under the current regulatory frameworks, please contact us at email@example.com.
1 An Information Guide for Healthcare Professionals on Biosimilars in the EU – Link here
2 Commission Q&A on biosimilar medicines for patients available in all 23 EU languages – Link here