Biosimilar Comparative Efficacy Studies: An Evolving Debate Promotion

The debate over whether the biosimilar regulatory paradigm can shift away from comparative efficacy trials has intensified over the past few years. This collection of articles serves as a snapshot of the many different components of this ongoing discussion. In addition to articles arguing why it is time to move forward, it's also important to acknowledge what has been learned from these clinical trials, what challenges they will pose in the near future, and in which situations clinical trials may serve as a valuable differentiator in the competitive future market place.