European Biosimilars Guidelines

October 17, 2011 2:48 PM

The legal framework to approve biosimilar products came into force in 2003 in the EU as discussed before. Today, we would like to go into more details and draw a general picture about the current and upcoming regulatory landscape in the EU. 

The legal route for biosimilar approvals was first introduced in 2003 in the European Union. According to the Directive 2001/83/EC, Article 10, Section 4:

Where a biological medicinal product which is similar to a reference biological product does not meet the conditions in the definition of generic medicinal products, owing to, in particular, differences relating to raw materials or differences in manufacturing processes of the biological medicinal product and the reference biological medicinal product, the results of appropriate pre-clinical tests or clinical trials relating to these conditions must be provided. The type and quantity of supplementary data to be provided must comply with the relevant criteria stated in the Annex and the related detailed guidelines. The results of other tests and trials from the reference medicinal product’s dossier shall not be provided.

As shown in our article “Biosimilars approved in Europe” EMA (previously EMEA) established several guidelines for biosimilars and renewing their guidelines although world’s biggest biopharmaceuticals market United States has no specific guidelines yet.

Since 2006, EU has approved seven different submissions under 14 trade names. The first approvals back in 2006 were for somatropin, a growth hormone and the rests were G-CSF and Epoetin biosimilars. With the upcoming patent expiries of well-known monoclonal antibodies (i.e. Herceptin, Enbrel), EMA Biosimilars Working Party is actively discussing biosimilar monoclonal antibodies in the recent years.

In 2009, preliminary discussions about the guideline has started in an EMA workshop. In October 2009, EMA published a concept paper and in November 2010, Europe’s regulatory watchdog published a draft guideline which was open for comments till May 2011.

Now, the Final Guidance for monoclonal antibodies are waiting to be published and EMA was asked several scientific advices while the companies are developing their copycat versions of highly complex monoclonals. If you want to check the “Guideline on similar biological medicinal products containing monoclonal antibodies” before it is officially published, you can check the latest draft version here:


Sources: EMA, Reuters


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