FDA study could lead to halving biosimilars development costs

A study published Wednesday could lay the groundwork for a dramatic reduction in the cost and time required to develop biosimilars and interchangeable biosimilars in the United States. It was released at a time when FDA is reconsidering the biosimilars review paradigm, including the need for Phase III trials to confirm safety and efficacy. 

FDA officials reviewed the effects of switching patients to or from a biosimilar and its reference product, concluding that there were no safety concerns. ...