In response to industry feedback for deeper insights on the hot topic of biosimilars or follow-on biologics (FOBs), a spotlight panel titled “Biosimilars: Risk taking vs. Caution?” has been added to the programme at BIO-Europe Spring conference, held on 7-9 April 2008 at the Palacio Municipal de Congresos, Madrid.
The biosimilars panel will be led by Dr Ludger Wess, Managing Partner, akampion, and held on Monday 7 April.
Dr Wess will be accompanied by a distinguished panel featuring Steve Usdin, Senior Editor, BioCentury Publications; Dr Thomas Brennecke, Head Business Development, BioGeneriX AG; and Cecil Nick, Principal Consultant, PAREXEL Consulting.
Commenting on the biosimilars spotlight panel, Dr Wess stated: “After years of discussions, the consensus view is that an expedited approval pathway for follow-on biologics (F0Bs) will soon be established in the United States, following the example of the EU. Even some of the most steadfast opponents of FOBs have come to the realisation that their ‘just say no’ and ‘the science isn’t here yet’ arguments are no longer tenable. Against this backdrop industry must now navigate the shoals of uncertainty as the US Congress, the FDA, EMEA, and indeed the rest of the world slowly begin to roll out their own, unique regulatory policies for approval of FOBs.
“In Europe the EMEA appears to be very cautious, but nevertheless has moved forward on a case-by-case approach for each biological and each indication. The US approach is still very uncertain and may be influenced greatly by what happens in the presidential elections in November. It is clear, however, that the political tide has shifted in the US and it is no longer a question of if legislation will be passed, but when. Our panel of experts will discuss how the different approaches affect their decision making process and the positioning of their products.”