An interview with Uwe Gudat from Merck Serono, speaker at the 4th Annual Biosimilars & Biobetters Congress, 18-19 April 2016, London

In anticipation of our 4th Annual Biosimilars & Biobetters Congress, we spoke to one our expert speakers about the some of the key issues in the industry. Uwe Gudat from Merck Serono gave us his thoughts on how the field of biosimilars is developing, safety and regulatory requirements and more.

We asked Uwe to give a brief introduction to highlight some aspects of what his presentation will cover:

“I think product safety for a biosimilar is given by the structural congruence with the originator. The premise being that if molecular structure determines clinical behaviour, then a high degree of structural resemblance translates into comparable clinical performance – that’s the whole logic of a biosimilar.”

When discussing how to convince clinicians of a biosimilar product’s interchangeability with the originator, he noted:

“Information is key – clinicians have to understand the logic behind the biosimilars pathway and appreciate that the analytical characterisation and the comparison against the originator with respect to structure gives a high degree of reassurance regarding the safety of the product.”

The full interview is available to read here

Uwe will be presenting at the 2016 Congress on the topic of ‘Managing Biosimilar Safety: From Bench To Bedside’.

4th Annual Biosimilars & Biobetters Congress

The congress will also feature the following speakers and topics:

• Mourad Farouk, Global Head of Medical Affairs, Biosimilars at Biogen Idec will be discussing immunogenicity issues
• Steinar Madsen, Medical Director at the Norwegian Medicines Agency, will present on the implications of Infliximab biosimilars for the industry
• Rakesh Dixit, Vice President at MedImmune, will present on the complexities associated with the choice between a biosimilar or biobetter development pathway

To review the conference programme and list of speakers click here

Registration Contact Danielle Dalby today on d.dalby@oxfordglobal.co.uk or call +44(0)1865 248455 to secure your place. Limited places now available.