FDA Tweaks Biosimilar Application Review Program

Samsung Bioepis Executive Comments on Kaiser Permanente’s Biosimilar Success

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.

Dr Gary Lyman: Are Interchangeability Designations for Biosimilars Meaningful?

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.

Opinion: The Debate Over Animal Toxicology Studies

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.

The Top 5 Biosimilar Articles for the Week of August 30

September 3rd 2021

Here are the top 5 biosimilar articles for the week of August 30, 2021.

Meta-analysis of Sandoz Pegfilgrastim PK/PD Studies Supports Biosimilarity

September 2nd 2021

By Deana Ferreri, PhD

A meta-analysis of pharmacokinetic (PK)/pharmacodynamic (PD) characteristics of Sandoz pegfilgrastim biosimilar confirms biosimilarity.

McKesson’s Catherine Swick Discusses Oncology Biosimilars

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.

Biosimilars Roundup: Policy and Business Developments Signify a Busy August

August 31st 2021

By Tony Hagen

Policy developments, business milestones, and physician-led efforts to shape biosimilar absorption made August 2021 an active time for these lower-cost biologics.

Report: Physician-Patient Education Can Improve Biosimilar Acceptance

August 31st 2021

By Tony Hagen

Misperceptions of biosimilars contribute to low acceptance of these products. Two Cardinal Health researchers discuss barriers to understanding and the importance of biosimilar education.

Ranibizumab Biosimilar (Byooviz) Gains EU Marketing Authorization

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.

Opinion: How to Get FDA Clinical Efficacy Testing Waivers for Biosimilars

August 28th 2021

By Sarfaraz K. Niazi, PhD

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.