‘Biosuperiors’ or ‘biobetters’ are improvements to originator biological molecules, whereas biosimilars are structural imitations of the originator. While biosimilars promise the same effect at a reduced price, a biobetter will possess some molecular or chemical modification that constitutes an improvement over the originator drug and its biosimilar competitors.

The enhancement may range from better efficacy, or a longer half-life, allowing for a lower dosing frequency and reduced risk of immunogenicity, to lower toxicity and reduced side effects. Such improvements can be made by identifying how changes to protein folding impact on the effects of a drug. The drug can then be modified by protein or glyco-engineering. But the major benefit of biobetters is the fact that they have lower early-stage research and development costs.

According to Dr Stephen Porter, Chief Scientific Officer at Dragon Bio-Consulting, Hong Kong, China, ‘the game’s not in biosimilars, it’s in biobetters.’ Dr John Hubbard, Senior Vice President, Worldwide Development Operations, Pfizer USA, agreed, describing biobetters, not biosimilars, as ‘the market opportunity.’

Bringing these products to market will require clinical trials and this represents an opportunity for CROs. Dr Mark Goldberg, Chief Operating Officer at Parexel, Boston, USA, said his CRO has made a concerted effort to enter the sector with a deal signed in January 2011 with Merck Bioventures, the biosimilars division of Merck Sharp and Dohme.

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