Preparing for the Arrival of Follow-On Biologics

A handful of follow-on biologics are already offered in European and American markets, but have yet to cause signifi cant brand erosion. Yet despite ongoing regulatory and commercial uncertainties, Big Pharma and small molecule generics companies have been making strategic moves to enter into the biosimilar arena. This article, written by experts from the Campbell Alliance, examines the current movement toward an abbreviated approval pathway for follow-on biologics in the US and assesses the potential impact on current biotechnology products. In addition, the article provides some insight into what commercial and reimbursement decision makers for biotechnology companies should be doing to prepare for the arrival of biosimilars.