Are Biobetters Better?

Biosimilars and biobetters are both variants of a biologic drug, however, while biosimilars are close copies of the originator, biobetters have been improved, for example, in terms of efficacy, safety, tolerability or dosing regimen.Regulators consider biobetters as new products and so afford them the same patent protection as any originator, however, this means they require the same clinical and non-clinical data packages. Conversely, a reduced clinical data package is an attractive element for the development of biosimilars.Given the cost of development and the time pressure to bring a biobetter to market before biosimilars push prices down, some are asking a fundamental question – are biobetters worth the investment?No better?One way of improving an originator is through PEGylation – modifying a biological molecule with polyethylene glycol (PEG), a non-toxic, non-immunogenic polymer. This process can be used to change the properties of the molecule to, for example, increase drug stability and reduce drug administration frequency.Such a technique has been used to adapt several molecules, including anaemia drug Mircera (methoxy polyethylene glycol-epoetin beta) and infection-fighting drug Neulasta (pegfilgrastim), a PEGylated version of Neupogen (filgrastim). Both products were developed to reduce dosing frequency without diminishing efficacy.However, more convenient dosing schedules may reduce healthcare burden but do not always translate into value for payers. For exam...
Source: EyeForPharma - Category: Pharmaceuticals Authors: Source Type: news