The current status of biosimilar biologics – Part 2: Practical considerations in international development through European lessons learned

Biotech products coming off patent afford a window of opportunity to obtain a marketing approval for a “follow-on” by a new product developer. If the supporting data are sufficient to authorise interchangeability or substitution then the new product is defined as a similar biologic or “biosimilar”. Europe is leading the way in defining the regulatory pathway for biosimilars. This article – the second in our two-part series on the biosimilars landscape – shares lessons learned from successful European development and approvals that can provide strategic insights to guide future biosimilar development plans. Read More