As the debate rumbles on about biosimilars, DrugBaron cannot help wondering if they are not in any case the wrong solution to a very real problem. After all, when it comes to biologic drugs is biosimilar similar enough?
The principle of generic drugs mostly works very well, ensuring that at the end of the state-sponsored monopoly period, which allows super-normal profits to compensate and incentivize innovators, normal market economics applies to drug pricing.
It works because almost everyone (medical professionals and patients) believe the generic to be functionally identical to the proprietary drug. Not just similar, but identical. The initial high price was pay-back for discovering and developing the drug in the first place, not a premium for quality.
Biosimilars attempt to extend the same principle to biologic drugs. But the core tenet of the generics system (functional identity of the generic) is demonstrably absent. Healthcare professionals and patients will not, and should not, accept that similar is good enough.
Yet no-one can doubt the need to find a solution to the problem of indefinite premium pricing for biologics. As their ranks swell on the medicine cabinet shelf, it’s a pressing problem for the world’s healthcare providers.
Maybe, then, its time to look for a different solution? There is an alternative to biosimilars. Enshrine the principle of patent law directly into the regulatory framework for biologics: in return for approving the drug, ten years after approval the registrant must license others on pre-agreed terms to make the identical product. Such a system, creating true ‘biogenerics’, would allow market economics to determine the price of biologic drugs while providing the patients with the real product, backed by extensive hard end-point clinical trial, not some cheap imitator.
RxCelerate Ltd is an outsourced drug development platform based near Cambridge, UK. We specialize in delivering an entire road map of drug development services from discovery and medicinal chemistry through to formal preclinical development and clinical up to Phase IIa. In the last five years, we have witnessed dramatic changes in the drug development …
