Newsletter | February 4, 2016

02.04.16 -- Choosing Between Patent And Trade Secret Protection In A Biosimilar World

Biosimilar Development
Featured Editorial
Should The Biosimilar Industry Worry Over AbbVie's IPR Triumph?
By Anna Rose Welch, Editor, Biosimilar Development   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?
Choosing Between Patent And Trade Secret Protection In A Biosimilar World
By Paul A. Calvo, Ph.D.   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?
Choosing The Right Rapid Prototype Source For Device Development
Phillips-Medisize   Phillips-Medisize
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.

Explore the program agenda here.
News Headlines
NICE Issues Final Guidance Recommending 7 Drugs For Rheumatoid Arthritis
Sandoz Licenses Its Biosimilar Rituximab To Kyowa Hakko Kirin In Japan
FDA Accepts Amgen's Biosimilar Biologics License Application For ABP 501
Biosimilars Blog
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Norway To Offer Benepali At 47% Discount
Don’t Expect Extrapolation For Next-Gen Biosimilars, Expert Says
Chinese Market To See Increased Sterile Injectable Production

For these and other headlines, click here.
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