The life of a drug is well established: a compound is patented. It’s then clinically trialled, approved for sale, and then when the patent expires generic companies mass-produce it. Sales then collapse for the innovator company.
But there are some drugs to which this cycle doesn’t apply: biologics.
These are complex molecules, created from cell lines, consisting of tens of thousands of atoms. Generic companies can’t copy them as they’re too complicated.
Biologics aren’t unusual.
Roche generates the vast majority of its sales from biologics: its most famous is Herceptin, used to treat breast cancer.
Biosimilars are attempts at making a generic of a biologic.
They’re not identical copies but they’re very similar.
A crucial difference between normal generics and biosimilars is that biosimilars must be clinically trialed to show it’s no different to the original drug. If it can, regulators will approve it and it can be used instead of the original drug.
Who makes biosimilars?
The usual suspects: Novartis, Merck and Pfizer are all developing biosimilars for their competitors’ drugs.
Some of the higher tech generics companies – Mylan, Teva, Allergan – are also getting in on the act.
3 years ago, there were no biosimilars.
Now there are several, and the number is growing.
$35bn of US sales are targeted from the top 14 biologic drugs alone.
By 2019, there could be approved biosimilars for 12 biologics.
This is good news for consumers, as biosimilars are normally priced ~20-40% cheaper than the original.