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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.

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

Tony Hagen is senior managing editor for The Center for Biosimilars

The recommendation from Europe's Committee for Medicinal Products for Human Use (CHMP) bodes well for a final marketing authorization for the adalimumab biosimilar candidate. 

Celltrion's CT-P17 Gains CHMP Recommendation for EU Marketing

The approval of HLX03 marks the third biosimilar regulatory success in China for Henlius. 

Shanghai Henlius Biotech Gains China's Approval for Adalimumab Biosimilar

The merger of Pfizer's Upjohn division and Mylan has created a biosimilars powerhouse with global reach. 

Newly Created Viatris Joins the Biosimilars Forum

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. 

Alvotech Scientific Officer Describes Company's Global Biosimilars Strategy

Minute differences between biosimilars and reference products are not considered “clinically meaningful,” but these differences are exploitable when it comes to addressing allergies related to originator products.

Providers Exploit Minor Differences Between Innovator Drugs and Biosimilars

Bincy P. Abraham, MD, MS, AGAF, FACG, is a professor of Clinical Medicine at Houston Methodist Academic Institute. She is also the distinguished professor and director of the Fondren Inflammatory Bowel Disease Program at the Underwood Center for Digestive Disorders and director of Gastroenterology Fellowship Program at Houston Methodist Hospital.

Bincy P. Abraham, MD, explains that even when payers allow coverage for biosimilars, providers may still be hesitant to use them. 

Opinion: Embrace the Era of Next-Generation Biologics

The rheumatology and gastroenterology biosimilar candidate would enter the lucrative market established by Humira.

Alvotech Files for US and EU Approval of Adalimumab Biosimilar

Investigators said their study is valuable because biosimilar switching is likely to increase for economic reasons. 

High Patient Retention Observed for Multiple Etanercept Switches

The International Generic and Biosimilar Medicines Association (IGBA) hopes to build momentum for the use of biosimilars. 

Rheumatology