When we buy own-brand paracetamol over the counter we are happy to assume that this is the same as a branded product. For simple chemicals identical compounds can be copied easily. Biologics, including antibodies and hormones, are considerably more complex. As such, blockbuster ‘branded’ biologics, like those used treat some forms of cancer, are also much more expensive.
Generic biologics are effectively ‘own-brand copies’ of these innovator, blockbuster, products. They could represent a huge cost saving for the NHS and a massive market for pharmaceutical companies; by 2016 $60bn of the biologics market will become available as innovator products lose patent protection. For life science researchers, law and business graduates this field hold enormous potential and controversy.
However, because of the complex nature of biologics and different manufacturing practices these ‘own-brand’ products cannot be considered identical. By bring industry, clinicians and researchers into a forum we ask: is similar good enough for generic biologics?
Keywords: drug development | business | life sciences | health policy
Mr Gavin Fitzgerald– Regulatory Affairs, Abbvie Pharmaceuticals
Dr Daniel Hawcutt– Senior Lecturer, Paediatric Clinical Pharmacology
Dr Jonathan Souquet – Process Development, Eden Biodesign
Wednesday, 16th October 2013
IACD Lecture Theatre, Ground floor, Duncan Building,
University of Liverpool
1530 – Registration
1600-1700 OBR & Speaker Introduction
1700-1800 Networking Reception
Registration essential at:
Join OBR to register for ‘Biosimilars: Controversies in Equivalence’
Contact for further details: Alan Mueller, firstname.lastname@example.org
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