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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.

Sarfaraz K. Niazi, PhD, discusses the regulatory approval of future messenger RNA (mRNA) vaccines, which will likely face fewer patent issues and are easy to replicate. 


Biosimilar mRNA Vaccines, Part 1: Regulatory Revolution!

Tony Hagen is senior managing editor for The Center for Biosimilars

Pfizer reported strong sales for its biosimilars portfolio, but these were eclipsed by the massive success of the company's mRNA vaccine for COVID-19.

Small Step for Pfizer's Biosimilars; Leap for Its COVID-19 Vaccine

Concomitant use of immunomodulators and dosage are important variables in the development of antidrug antibodies (ADAs) for patients receiving infliximab for Crohn disease, investigators report. 

Investigators Elucidate ADA Predictive Value of Infliximab Clearance in Crohn Disease

Biocon reports on its revenues from biosimilars and the FDA status of its insulin glargine product.

Biocon Updates on Semglee Interchangeable Status

Shanghai Henlius Biotech initiates a trial for patients with macular degeneration while Dong-A ST and Meiji Seika Pharma agree on a distribution plan for a ustekinumab biosimilar candidate. 

Henlius Initiates a Trial of Bevacizumab Candidate in Ophthalmology

Pharmacokinetic, safety, and efficacy findings for patients with inflammatory bowel disease (IBD) were presented at the European Crohn's and Colitis Organization's annual meeting. 

Investigators Report Findings on Infliximab Switching in IBD

Samsung Bioepis launches a potential pivotal trial for its SB17 ustekinumab biosimilar candidate. 

Samsung Bioepis Initiates Phase 3 Ustekinumab Trial

Amgen's advertising appeared to push doctors and patients away from the prefilled syringe version of its pegfilgrastim (Neulasta) product, which may have a better sales future than the Onpro.

How Risky Was Amgen's Onpro Advertising? 

Bio-Thera's BAT2206 ustekinumab candidate is in contention with multiple other proposed biosimilars to Janssen's Stelara. 

Bio-Thera Moves Ustekinumab Candidate Into Phase 3 Trial

Chad Landmon, JD, chair of Intellectual Property and FDA Practice at Axinn, Veltrop & Harkrider, provides a legal perspective on the implications of President Biden’s effort to improve the competitiveness of drug markets.

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