European Commission Offers New Q&A on Biosimilars

Regulatory NewsRegulatory News | 23 January 2017 |  By 

The European Commission on Monday unveiled a new question and answer document for those looking to better understand biosimilars.

Similar to the Focus explainer on biosimilars, the 9-page EC explainer, available in seven languages, offers a quick 10,000-foot view of the biosimilars landscape, answering questions that patients might have on what a biologic is, what a biosimilar is, how biosimilars compare to generics, what types of studies biosimilars must undergo prior to approval and how to define extrapolation.

In addition to offering links to additional sources of information for patients, the explainer also provides a quick rundown on what to do if a biosimilar leads to an adverse event, as well as a list of currently available biosimilars in the EU.

Meanwhile, for the third year in a row, the commission will also organize a multi-stakeholder workshop on biosimilar medicines on 5 May 2017. This year, the focus will be on developing a Q&A for healthcare professionals, the groups said in a statement. 

Q&A for patients - Biosimilar medicines explained


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