© 2021 MJH Life Sciences and Center for Biosimilars®. All rights reserved.
© 2021 MJH Life Sciences™ and Center for Biosimilars®. All rights reserved.
September 25, 2021
Biosimilar User Fee Act reviews have been slowed by the pandemic and the FDA has opened a public comment period as it plots the course through 2027.
September 24, 2021
September 23, 2021
September 22, 2021
September 6th 2021
By Tony Hagen
Kaiser Permanente got biosimilars into circulation by building physician confidence, a strategy that a Samsung Bioepis executive says should be employed more widely.
September 5th 2021
Gary Lyman, MD, MPH, an oncologist and hematologist, explains that biosimilar substitution in the absence of interchangeability designations is widespread and not without clinical merit.
September 4th 2021
By Sarfaraz K. Niazi, PhD
Animal toxicology studies still get included with biosimilar approval applications, although there are strong arguments that most of these studies are unnecessary. Sarfaraz K. Niazi, PhD, explains the pros and cons.
September 3rd 2021
Here are the top 5 biosimilar articles for the week of August 30, 2021.
September 2nd 2021
By Deana Ferreri, PhD
A meta-analysis of pharmacokinetic (PK)/pharmacodynamic (PD) characteristics of Sandoz pegfilgrastim biosimilar confirms biosimilarity.
September 1st 2021
Catherine Swick, MBA, senior vice president of Provider Strategy and Marketing at McKesson, discusses efforts to get oncology biosimilars into play at US Oncology Network.
August 31st 2021
Policy developments, business milestones, and physician-led efforts to shape biosimilar absorption made August 2021 an active time for these lower-cost biologics.
Misperceptions of biosimilars contribute to low acceptance of these products. Two Cardinal Health researchers discuss barriers to understanding and the importance of biosimilar education.
August 30th 2021
Byooviz, developed by Samsung Bioepis, will be distributed by Biogen in the European Union, where it becomes the first ranibizumab biosimilar. An application is under review with the FDA.
August 28th 2021
Clinical efficacy studies are not always required for biosimilars, and it's possible to resist if the FDA does ask for them. Sarfaraz K. Niazi, PhD, suggests a game plan.