Likelihood of big uptake of biosimilars by 2020 questioned

The engine of the biosimilar sector is the same as with small molecule drugs, patent expiry. On this basis, prospects for biosimilars look good, with the vast majority of leading originator brands in the global biologics market expected to lose some degree of protection by 2020.

All major countries now make provision for an abbreviated biosimilar development and regulatory pathway. Funds are flowing into the sector and many new partnership agreements have been signed. Everything in the biosimilar garden might look rosy, but what is the reality? asks pharma business veteran analyst Don Macarthur.

Biosimilar sales of $16 billion plus were forecast in the European Union and USA alone for 2011.This estimate turned out to be 50-times too high. With payer encouragement, there have been pockets of success with some molecules, but development and market access is taking much longer than expected.