Newsletter | February 18, 2016

02.18.16 -- How Pharmacists Can Benefit Biosimilar Development

Biosimilar Development
 
Featured Editorial
Cinfa Biotech: How Pharmacists Can Benefit Biosimilar Development
By Anna Rose Welch, Editor, Biosimilar Development   By Anna Rose Welch, Editor, Biosimilar Development
Developing a biosimilar is a highly scientific process. To ensure the biosimilar demonstrates the same efficacy and safety profile as the reference product, the science and clinical data have to match up. However, as Ruediger Jankowsky, managing director of Cinfa Biotech, says, a company should approach biosimilars from the “pharmacist’s perspective,” which extends far beyond the science of a biosimilar.
Key Design Considerations On Comparative Clinical Efficacy Studies For Biosimilars: Adalimumab As An Example
By Zhihong Lai, GSK, and Anna La Noce, Worldwide Clinical Trials   By Zhihong Lai, GSK, and Anna La Noce, Worldwide Clinical Trials
The global development of a biosimilar product is a complex affair, lined with potential design pitfalls and operational missteps to be avoided. Owing to the focus on demonstrating biosimilarity and not safety and efficacy de novo, designing an adequate Phase 3 efficacy study of a biosimilar may present some unique challenges.
Systems Engineering For Complex Portable Medical Device Development
Phillips-Medisize   Phillips-Medisize
As the demand for complex, portable medical devices continues to grow, reducing risk and increasing efficiency during the development of these products should be paramount.
News Headlines
JHL Biotech Receives Approval From European Authorities To Begin Biosimilar Clinical Trial
Sandoz Acquires Pfizer's Biosimilar Infliximab In EEA
EMA To Review Regulatory Submission For Sandoz Biosimilar Pegfilgrastim
Biosimilars Blog
 
  Read this week’s blog posts on:
• Presidential Budget Pushes For Lower U.S. Biologics Exclusivity Period
• FDA Committee Gives Nod To Celltrion For Full Remicade Label
• Biocon To Seek FDA Approval For Biosimilars

For these and other headlines, click here.
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