By Anna Rose Welch, editor, Biosimilar Development
One oncology expert shares his thoughts on the operational challenges biosimilars may pose hospitals and what biosimilar manufacturers need to consider as they continue to invest in and launch oncology biosimilars.
Fiscal year 2019 was a fascinating year for drug GMP warning letters in the diversity of topics addressed, depth of focus, and trends in enforcement actions. This article presents a comprehensive summary of the drug GMP warning letters issued in FY2019, including an evaluation of trends since FY2013.
With all the promise biosimilars hold, why we are not seeing increased market uptake? There are many reasons that involve policy, legislation, and the legal system that have led to the current state of the biosimilar market in the U.S. This white paper examines the basics.