Newsletter | February 11, 2016

02.11.16 -- How Biologics Manufacturing Transparency Could Bolster The Biosimilar Market

Biosimilar Development
 
Featured Editorial
What Amgen And Biosimilar Makers Stand To Gain From AbbVie's IPR Win
By Anna Rose Welch, Editor, Biosimilar Development   By Anna Rose Welch, Editor, Biosimilar Development
Amgen's IPR upset is being viewed as a big setback for the biosimilar industry. However, when considering the fact that Amgen is both an innovator and biosimilar maker, this loss carries with it an interesting benefit for the biosimilar industry.
USPTO Activity Signals Shift In Pharmaceutical Patents Treatment In AIA Proceedings
By Arlene Chow and Ernest Yakob, Ph.D., Hogan Lovells   By Arlene Chow and Ernest Yakob, Ph.D., Hogan Lovells
Several recent decisions by the United States Patent and Trademark Office (USPTO) suggest that pharmaceutical patents could be faring better in America Invents Act (AIA) proceedings. While this bodes well for reference drug makers, these signs also suggest that biosimilar makers will have a more difficult time challenging pharmaceutical patents currently keeping their biosimilars off the market.
How Biologics Manufacturing Transparency Could Bolster Biosimilar Market
By Anna Rose Welch, Editor, Biosimilar Development   By Anna Rose Welch, Editor, Biosimilar Development
While there are still a number of questions remaining following the resolution of Amgen v. Sandoz, one particular question stands out following the Federal Circuit's decision: How much should pharma companies be required to share with each other?
Sponsor
  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 execute cost-efficient clinical trials.

Explore the program agenda here.
News Headlines
FDA's Arthritis Advisory Committee Recommends Approval Of Celltrion's CT-P13 Infliximab Biosimilar For All Indications
EPIRUS Biopharmaceuticals Initiates Pivotal Global Phase 3 Clinical Study For BOW015 (Infliximab Biosimilar)
New Drugs From Abbvie, Gilead, Intercept, And Merck Forecast To Achieve Blockbuster Status By 2020
Assessing The Biosimilarity Of Protein Drugs: New Study Shows Method's Precision At Atomic Resolution
Biosimilars Blog
  Read this week’s blog posts on:
Woodcock: More Funding Needed For Biosimilar Review Program
WHO Issues Final Naming Proposal
Upcoming Celltrion Review Could Pave Way For Extrapolation

For these and other headlines, click here.
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