World GI 2017: Biosimilars: How Much Evidence Do We Need?

The interest of producing biosimilars is that we don't need to repeat all the studies needed for the original. The closer you can prove you are from the original product, the less clinical studies you will be required to do.
Speaker: Mario Dicato

Mario Dicato explains that the use of immuno-oncology has increased the costs of treatments which were already unaffordable for some countries.

The major interest now is on monoclonal antibodies. They are being produced by cells in a genetic engenering process. Bacterias are commonly used for that and are cheaper but if the product needs to be transformed after production, eucaryotes have to be used instead. At first, the original companies own the patent for the cell line but even when they have expired, developing the technique is still expensive.
Biosimilar will necessarily bring down the price of the original product but the cost of the technical procedure is still a major barrier. For this reason, the EMA has expressed clear rules to favour the production of biosimilars to bring competing drugs to the market.