Newsletter | January 28, 2016

01.28.16 -- Do Biosimilars Fit Into The Innovation Paradigm?

Biosimilar Development
 
Featured Editorial
Do Biosimilars Fit Into The Innovation Paradigm?
By Anna Rose Welch, Editor, Biosimilar Development   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.
5 Questions To Ask About Biosimilars In 2016
By Andrew Williams, Partner, McDonnell Boehnen Hulbert & Berghoff LLP   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.
How To Maximize Efficiencies Of Medical Product Development During Pilot Phases And Clinical Trials
Phillips-Medisize   Phillips-Medisize
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.
News Headlines
BIOCAD Announces The First Trastuzumab Biosimilar Approved By The Ministry Of Health Of The Russian Federation
Sterile University To Train Drug Manufacturing Workforce In China
Halozyme Announces First Clinical Dosing Of Adalimumab (Humira) Using ENHANZE™ Technology
University Of Maryland School Of Medicine Research Leads To FDA Approval Of Crucial Drug For Radiation Sickness
Biosimilars Blog
 
  Read this week’s blog posts on:
FDA’s CDER Announces 2016 Guidances
PhRMA, BIO File Petition With Labeling Demands
Oncobiologics Files IPO To Bolster Biosimilar Development

For these and other headlines, click here.
Connect With Biosimilar Development:
Twitter