The U.S. may be arriving late to the biosimilar market, but it can make up the lost time through a speedier adoption of the follow-ons.
"I think the pendulum is swinging to the other direction" when it comes to adoption, Siegmund Gutman, a partner at Proskauer Rose LLP, told BioWorld Today. The EU may have taken the lead in developing the market, but it hasn't been quick on the uptake, he noted. The U.S., facing the pressure of higher drug prices, could be much faster in adopting biosimilars, especially when the FDA opens the pathway for interchangeables.
Robert Cerwinski, a partner at Goodwin Procter LLP, agreed, saying an acceleration in the uptake of biosimilars is very likely in the U.S., but it's tough to predict the rate of that acceleration. Interchangeability, which allows for automatic substitution, will be a major factor.
The EU path has no separate development for interchangeables and leaves biosimilar