Biosimilars

These medicines are similar to generics but with the key difference being that the medicine going off-patent is derived from a biotechnology product (biopharmaceutical).

 

With biopharmaceuticals losing their patent protection this means that they can be developed and manufactured by other companies.  This in turn ensures that patients have access to safe, effective and more affordable biotechnology-derived medicines.  Biopharmaceuticals cost about twice as much as conventional pharmaceuticals and many patients who need biopharmaceutical treatment are unable to do so because of cost.  Therefore it is important that biosimilars are made readily available for these patient groups.

 

In the same way as generics, when biosimilars are assessed, they have to demonstrate the same quality, safety and efficacy as the biopharmaceutical.  In addition to this data, the company developing the biosimilar must also demonstrate comparability.