Bio-equivalent drugs. biosimilars
When the patent time of an original drug has expired (often after 15 years), other than those who have the copyright, may produce similar medication. They avoid a lot of development costs, and the new drug becomes cheaper. Since original biological drugs are very expensive, about 30% costs savings of several tens of thousands Norwegian kroner annually for each patient receiving treatment. Saved drug costs can be used in other areas of health care.
Some Bio-equivalent antirheumatic drugs
- Adalimumab (Humira is the original)
- Etanercept (Enbrel is the original)
- infliximab (Remicade is the original)
- Rituximab (MabThera is the original)
Et Biological drug that Remicade (Infliximab), Enbrel (Etanercept) and Humira (adalimumab) is made using living organisms such as bacteria, fungi and cell cultures and is therefore called "biological drugs". The biological drugs used against rheumatic diseases are so-called monoclonal antibodies that block parts of the immune system.
Bio-similar drug is based on an original biological drug. The amino acid composition is similar, but the chemical structure may be different.
The effect of bio-equivalent drug should be similar to the original. Small variations also occur within the originals when produced at different times
The adverse events
The side effects should not differ from the original
Insecurity nevertheless consists concerning effects and side effects since the production of bio-equivalent drugs is very complex. The copy producer must develop own cell colonies and create synthetic genes that encode a protein that is as similar to the original as possible. Although extensive effects and safety studies are done, the drugs are not completely identical.
The use of Remsima and Inflectra as bio-equivalent drugs for Remicade increased sharply in Norway after its introduction in February 2014 and already as of 2015 accounted for 75% of the market. In Denmark, the corresponding figure was 94%, but in Sweden only 6,7% (as of September 2015 according to Today's Medicine)
A Norwegian medical study (NOR-SWITCH)
To investigate whether switching to bio-similar drugs is uncomplicated, a separate study ("The NOR-Swich study“). The leader of the study was Professor Tore Kvien at Diakonhjemmet's hospital in Oslo. The study is of great interest nationally and internationally, and funds were allocated from the state budget for the implementation. The results were presented in 2016 and showed that the effect and adverse event of bio-similar infliximab (Remsima, Inflektra) was comparable to the original composision (Remicade). Replacement from the original preparation to bio-equivalent drug is therefore considered safe.