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?
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 Life sciences companies are well advised to take proactive steps knowing the draft guidance signals change is underway.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.
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.
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.