Newsletter | January 21, 2016

01.21.16 -- Biogen: Embracing Biosimilars In A Biologics World

Biosimilar Development
 
Featured Editorial
Biogen: Embracing Biosimilars In A Biologics World
By Anna Rose Welch, Editor, Biosimilar Development   By Anna Rose Welch, Editor, Biosimilar Development
Despite the fact biosimilars pose a big threat to the company’s novel biologics, Dr. Alpna Seth, Biogen’s VP and head of the biosimilars business unit, says jumping into the biosimilar space was a natural move for the company because of its advanced biologics capabilities.
Intellectual Property Issues Under The Trans-Pacific Partnership
By Joseph Reisman, Sheila Swaroop, and Scott Seeley, Knobbe Martens   By Joseph Reisman, Sheila Swaroop, and Scott Seeley, Knobbe Martens
Biologics exclusivity was one of the most controversial issues holding up the recently finalized Trans-Pacific Partnership (TPP) negotiations. Following the release of the official text of the TPP, there are three intellectual property provisions that biologics and biosimilar makers will need to keep in mind as they continue to navigate the global market.
6 Guidelines To Follow When Developing Combination Products
By Winston Brown, VP of Global Quality, Phillips-Medisize   By Winston Brown, VP of Global Quality, Phillips-Medisize
While the development of a combination product comes with significant patient benefits through technology and molecule innovation, that reward can be offset by the range of regulatory complexity and uncertainty encountered with bringing a product to market, in addition to any post-marketing activities.
News Headlines
BENEPALI, The First Etanercept Biosimilar Referencing Enbrel, Approved In The European Union
Xbrane Signs Deal With Helvetic BioPharma For Lucentis Biosimilar, Xlucane
Van Eck Launches Market Vectors Generic Drugs ETF (GNRX)
Biosimilars Blog
 
  Read this week’s blog posts on:
Celltrion’s Infliximab FDA Review Date Announced
Amgen’s Humira Patent Challenge Rejected By PTAB
CHMP Reviewing Mystery Humira, Insulin Biosimilar Candidates

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