France's new biosimilars law creates a framework for a restricted form of substitution of innovator biologics. But how the law will actually be implemented won't be finalized until a ministerial decree is published, which could come as soon as 2Q14.

The French Parliament passed biosimilars legislation in December as part of the 2014 Social Security Finance Act (PLFSS). The law stipulates that a pharmacist can substitute a biosimilar when a doctor prescribes an originator biologic if three conditions are met.