Newsletter | October 31, 2019

10.31.19 -- Global Biologics Access: What Is The U.S.' Role?

Featured Editorial
A Delicate Balance: Patent Exclusivity, Innovation, And Competition
By Anna Rose Welch, editor, Biosimilar Development

Overall, arguments calling into question the value of biologics competition tie into what I think is an even more important question worth asking in this country: What global responsibility does the U.S., as the largest pharmaceutical market, have in terms of promoting greater access to medicines?

FDA’s New Population Pharmacokinetics Guidance: What You Need To Know
By Scott Thiel and Liisa Eisenlohr, Navigant

The FDA’s Population Pharmacokinetics Guidance for Industry draft calls for sponsors of new drug and biologics license applications to apply population pharmacokinetic (PK) analysis. Life sciences companies are well advised to take proactive steps knowing the draft guidance signals change is underway. Moving forward, pharma/biopharma and medical device developers should continue to implement appropriate mechanisms to help ensure the safety and effectiveness of drugs and devices for patients.

Industry Insights
Your Strategy To Manufacture, No Longer A One-Size-Fits-All
Article | By Olivier Loeillot, GE Healthcare Life Sciences

The traditional method of big batch manufacturing must change as companies move away from the one-size-fits-all blockbuster model toward more innovative, targeted biologics that deliver better outcomes.

The Ups And Downs Of Biosimilar Development
Podcast | Bio-Rad Laboratories, Inc.

Biosimilar KOL, Dr. Paul Rhyne, chief scientific officer and vice president of bioanalytical operations at Biologics Development Services (BDS), provides an overview of the current state of biosimilars and their global impact.

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