Biosimilars, Part 3: Interchangeability

In recent editorials, I have discussed two major issues involved in biosimilars: intellectual property protection (see more on p. 46) and the comparability standard. Now, let's consider the third holy grail of biosimilars: interchangeability.

Under the new US biosimilars legislation, the FDA will decide whether or not to designate a biosimilar as interchangeable with its reference product. Under such a designation, the biosimilar may be substituted for the reference product without involving the prescribing physician. The stakes surrounding this determination are high. If a biosimilar is not designated as interchangeable with its reference product, the manufacturer will achieve …