Industry Expert Says Interchangeability Studies Likely to Require Several Switches

Clinical trials to prove biosimilar interchangeability with reference products will likely involve multiple switches between the products, an industry expert said.

The FDA has not issued draft guidance on biosimilar interchangeability, but Hillel Cohen, executive director, scientific affairs at Sandoz Biopharmaceuticals, said approval for a biosimilar that can be substituted for its reference product will probably hinge on clinical data that evaluate several switches between the products.

While a biosimilar is approved based on studies that demonstrate it is highly similar to the reference product, interchangeable biosimilars will have to meet additional standards, the FDA said.