Key recommendations for small biotech firms that are considering developing a biosimilar
• Timing matters: Market awareness will be highest for the first biosimilar to compete with a given originator. In our view, it does not make
sense to develop the 13th EPOsimilar as nobody in the market will be interested in such a product.
• Dare to be different: As previously discussed, a biosimilar has to overcome the healthy scepticism of the prescribing community and as a biosimilar
will not offer efficacy advantages (and eventually safety too), attractive pricing alone will not always convince the market.
Try to find targets where you can positively differentiate your biosimilar; for example, with an optimised formulation, delivery
modes, packaging variants, sizes and service aspects of the product offering.
• Keep it simple: Try to find targets for which you can access the knowledge around the product, its development and production processes,
and then try to stay as close as possible to this foundation as this has proven its viability through the originator for many
• Don't play on IP: There are not many defence strategies available to the originator firm, so you may expect it to fully exercise its options.
Eventually the battle for market share in many cases will not be fought at the prescriber's desk, but long before at the patent
attorney's desk. As such, you must find a way around IP issues or you may be taking part in a game too heavy to play for a
• Prepare deep pockets for financing the unexpected: Eventually at the beginning of your development you draw a plan that nicely sums up to an interesting investment. Don't
sell this to your board as the final bill. You have a high chance to run into additional costs while in development. These
may result from a changing regulatory or IP environment, evolving market expectations or simply out of the fact that it is
difficult to do everything right the first time.
Anjan Selz is CEO at Finox AG