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Clinical

Tony Hagen is senior managing editor for The Center for Biosimilars

Investigators looked at the first 9 months of use following the launch of the bevacizumab biosimilar Mvasi to gauge physician comfort with this agent across tumor types.

Swift Uptake for Mvasi Suggests Provider Comfort With Use

CMS looks to speed up health information transfer by putting faxes in the past. It also aims to set deadlines for payers to respond to prior authorization requests. 

With New Policy, CMS Promises to Exit "Stone Age" of Health Information 

A need for clinical evidence on the efficacy and safety of infliximab switching led the authors to pursue this investigation.

Infliximab Biosimilar Switching Study Yields Evidence of Safety, Efficacy

Authors of a review found that biosimilar uptake and market share are not in themselves sufficient to establish whether these agents will lead to savings.

Economists Probe Cost-Effectiveness of Biosimilars

Product differentiation by concentration is a threat to the multiple adalimumab biosimilars approved but not yet launched.

Adalimumab Biosimilars Face Product Obsolescence Before Launch

Among patients treated for metastatic breast cancer, 40% switched to ABP 980. 

Investigators Chart ABP 980 Biosimilar Uptake in European Clinics

Christophe Bourdon, senior vice president and general manager of US Oncology for Amgen, discussed the development and marketing plan for the company's newly approved rituximab biosimilar. 

Amgen's Bourdon Discusses Riabni Rollout in the United States

The Canada Health approval for Hyrimoz will be followed by a launch in February 2021, Sandoz Canada said.

Sandoz Canada Gains Marketing Approval for Adalimumab Biosimilar

Sarfaraz K. Niazi, PhD, is an adjunct professor of biopharmaceutical sciences at the University of Illinois and the University of Houston, and founder of biosimilars companies Karyo Biologics and Adello Biologics. He also founded the biosimilar advisory company PharmSci.

Boehringer Ingelheim's argument hinges on how "strength" of formulation is defined in regulatory language.

Opinion: Boehringer Ingelheim May Win Regulatory Language Change Despite Weak Argument

Joseph E. McClellan, PhD, MBA, discussed navigation of regulatory hurdles as the company continues its quest to line up distribution partnership deals across the globe. 

Gastroenterology