Biosimilars Panel: Return to Starting Block for 'Biobetters'
LONDON – While the development of biosimilars – biological medicines designed to be very similar to ones that have already been approved for clinical use – is really still in its infancy, people already are looking to the future and considering what sorts of molecules will come next.
Anyone who thought that the son-of-biosimilar might be something that is bigger, better and more important than a biosimilar itself – a kind of molecule that has been dubbed a "biobetter" – may have another thing coming, however.
A panel discussion on "Biosimilars vs. Biobetters" at the Second Biosimilars Congregation 2013 this week addressed the issue of what biobetters are, and what role they have in relation to biosimilars.
The panelists – Anne Cook, biologicals quality assessor of the UK Medicines and Healthcare products Regulatory Authority (MHRA); Paul Greenland, biosimilars and proprietary marketing director of EMEA at Hospira Inc.; and Jean-Yves le Cotonnec, CEO of Triskel Integrated Services – were all in agreement.
"To me," Greenland said, "a biobetter is essentially a new biologic. You can't really talk about them in the same discussion. The approval pathway for a biosimilar and a biobetter is completely different," he added.
Basically, if a product is a copy of a reference molecule and aims to have the same clinical efficacy and safety profile, then it is a biosimilar.
Cook took a similar view. "They should be completely separate issues," she said. "There is a lot of confusion around the terminology. For us, the term biosimilar means approval by the European Union biosimilar route, which is a specific way of approving a biological that is a copy of an originator product."
She encounters companies that are seeking advice from the MHRA about developing biosimilars. "But they still have the mindset that they are developing a new product."
Le Cotonnec likewise emphasized that the approach to producing a biosimilar is completely different to that for development of a biobetter. "With a biosimilar, as soon as you have selected your clone to make your copy molecule, and done your physicochemical studies, you go straight into scaling up your production to commercial scale, before you do your clinical studies. It is a totally different mode of thinking compared to producing a new biological," he said.
Of course, there is nothing to stop the development of variants of biological molecules (or variants of biosimilars, for that matter) as new biological therapeutics.
Cook pointed out that there are a lot of data publicaly available that can help in the development of new biologicals. But anything that actually aims to be different is not a biosimilar, nor even, probably, a biobetter, even though it may be a biological that turns out to be better than what has gone before.
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