EuropaBio welcomes new EMEA technical document on biosimilars

18.07.2007

The European biotechnology industry welcomes the European Medicines Agency's (EMEA) new guidance on biosimilar medicines, entitled "Questions and Answers on biosimilar medicines" .

This initiative reinforces the EMEA communication on "biosimilar" medicine and recognises the uniqueness of these products. It states that they cannot be classified as "generics" in the same way that chemical compounds may be, due to the differences stemming from the variability of the active biotechnological substance and its manufacturing process.

Further, the EMEA document clarifies that: 'since biosimilar and biological reference medicines are similar but not identical, the decision to treat a patient with a reference or a biosimilar medicine should be taken following the opinion of a qualified healthcare professional'. This effective advice against automatic substitution of one biological medicine over another reinforces the central role of the physician-patient relationship when using biotech-derived therapies.

EuropaBio's Chair of the Healthcare Council, Dr Andrea Rappagliosi said that "This document provides some clarification on the use of biosimilars and underscores the importance of the biosimilar regulatory pathway established in 2004. The EMEA has further strengthened its guidance on how to best protect patient safety and provide effective treatment."

Rappagliosi concludes that "The EMEA should be acknowledged for its leadership in drawing attention to the uniqueness of biosimilars and the need for a separate approach for the use of this new class of products to that of generics."

The Chair of EuropaBio's Biosimilar Working Group Thomas Bols cautioned: "Whilst Europe now has an approval system in place, allowing for the introduction of biosimilars on to the market, international authorities should perhaps give guidance on a number of issues. The Q&A is a good start but other issues such as (INN) naming, interchangeability and the label of a biosimilar need to be clarified as well."

https://www.bionity.com/de/news/66270/europabio-welcomes-new-emea-technical-document-on-biosimilars.html