By Anna Rose Welch, Editor, Biosimilar Development
Pharma is inundated with the term “innovation.” However, there are varying definitions of what innovation means in drug development. Now that the U.S. has seen its first approval, and biosimilars are becoming a bigger business opportunity, I’m left wondering where, and if, biosimilars fit into the innovation spectrum.
By Andrew Williams, Partner, McDonnell Boehnen Hulbert & Berghoff LLP
Not only did we see the U.S. release its first biosimilar, Zarxio, in 2015, but the Federal Circuit provided its first interpretation of the Biologics Price Competition and Innovation Act (BPCIA). Nevertheless, there are still a lot of unanswered questions, many of which are likely to be addressed in 2016.
The principal means of controlling the many variables in medical product development is to select the right supplier/partner, with the right mix of service offerings, to help guide your project.