Newsletter | March 31, 2016

03.31.16 -- What Can Biosimilar Makers Learn From FDA's Biosimilar Workload?

Biosimilar Development
 
Featured Editorial
What Does FDA's Biosimilar Workload Reveal About Emerging U.S. Market?
By Anna Rose Welch, Editor, Biosimilar Development   By Anna Rose Welch, Editor, Biosimilar Development
The FDA has faced questions and criticism over its slow progress with biosimilar-related policies. In the face of these questions, however, the FDA has not provided any estimates or figures about the size of the biosimilars review team or the team's workload. Now, a new review released by ERG breaks down the agency's workload volume and costs, giving clearer insights into how the U.S. biosimilar regulatory landscape is unfolding.
The Impact Of Reformulation Strategies On Pharmaceuticals, Biologics
By Eric K. Steffe, Bonnie Nannenga-Combs, Ph.D., and Gaby L. Longsworth, Ph.D.   By Eric K. Steffe, Bonnie Nannenga-Combs, Ph.D., and Gaby L. Longsworth, Ph.D.
As blockbuster drugs approach patent expiration, pharma companies are turning to a number of reformulation strategies to extend the novelty and patent life of their small molecule drugs and biologics. How do these reformulations impact innovators and generics/biosimilar makers alike?
Should Pharma Patents Be Exempt From Biosimilar Makers' IPRs?
By Anna Rose Welch, Editor, Biosimilar Development   By Anna Rose Welch, Editor, Biosimilar Development
Only a small percentage — six percent — of IPRs are directed toward the pharmaceutical industry. Now that the U.S. has its first biosimilar on the market, however, these tides are potentially turning.
Device Development For Pharmaceutical And Biologic Combo Products
Phillips-Medisize   Phillips-Medisize
Combination products are therapeutics combining two or more products that are regulated and sold as a single unit. When developing a combination product, there are many aspects that need to be considered. Read this white paper to learn about the regulatory and clinical development strategies that help define pharmaceutical and biologic combination products, the need for early establishment of regulatory and clinical strategies, and how to best understand user needs and determine product requirements.
News Headlines
Biocon's Insulin Glargine Receives Regulatory Approval In Japan
Biosimilars Blog
 
  Read this week’s blog posts on:
• EU Doctors Turning To Biosimilars More Readily
• Payers, Docs Unfamiliar With Biologics Variability
• Celltrion Now Dubbed Big Business In Korea By FTC

For these and other headlines, click here.
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