Biosimilars join a list of topics of mutual interest for the two agencies which they have identified as benefiting from the regular exchange of information and collaborative meetings.

Other ‘cluster’ specific areas are oncology, orphans, paediatrics, advanced therapy medicinal products, pharmacogenomics, vaccines, veterinary medicinal products, and new blood products.

According to a EMA report from June 2011 [1], the degree of interaction between the FDA and EMA has increased significantly since confidentiality arrangements were first signed between the agencies in 2003.

In Europe the regulatory frameworks for biosimilars are largely established, with both general guidelines and product specific guidelines, covering human insulin, somatropin, human growth hormone, erythropoietins, interferon-alpha, low molecular weight heparins and monoclonal antibodies, having been put in place by the EMA. The agency is also currently working on draft guidelines for a number of other product class specific guidelines, including interferon-beta and follicle stimulation hormone.

The US, on the other hand, is lagging some way behind the EU, which approved its first biosimilar back in 2006. One of the main problems is that the US, although it now has a legal pathway (with the approval of the Biologics Price Competition and Innovation [BPCI] Act, which was signed into law on 23 March 2010 by President Barack Obama), does not yet have a practical pathway with guidance defined by the FDA.

Editor’s comment

This collaboration with the EMA will help the US to sort out its guidance for biosimilars sooner rather than later.

Please feel free to share your thoughts via email to editorial@gabionline.net or in the comments section below. What are your views on this collaboration between the EMA and FDA? Do you think this will speed up the long-anticipated guidance for biosimilars in the US?

Reference

1. Interactions between the European Medicines Agency and U.S. Food and Drug Administration September 2009-September 2010. EMA/705027/2010. June 2011.