By Anna Rose Welch, Editor, Biosimilar Development
In the face of biosimilar competition, AbbVie has been outspoken about Humira's IP protection. Following the PTAB’s recent decision to dismiss Amgen’s IPRs against two of Humira’s patents, the biosimilar industry is likely feeling the impact of AbbVie’s IP investments. Could this decision be a major setback for the development of the biosimilar market moving forward?
By Paul A. Calvo, Ph.D.
Biologics are protected by patents that can slow or eliminate competition from generics as long as the patent remains in effect. However, as the biosimilar market grows, biosimilar manufacturers are just as likely to face competition from other biosimilar companies. But could filing for their own patents help biosimilar applicants limit competition from other biosimilar makers?
Successful prototyping begins with mechanical design that will operate properly when assembled and will be scalable for volume manufacturing. A working prototype can be a smooth progression if you employ the right resources and processes.
At the Biosimilars Clinical Studies And Analytical Similarity Summit we’ll be providing key insights from thought leaders into the biggest challenges in the analytical and clinical phases of biosimilar drug development, from responding to additional regulatory challenges, demonstrating the quality attributes needed to prove interchangeability, and successfully executing cost-efficient clinical trials.