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Tony Hagen is senior managing editor for The Center for Biosimilars

Ahead of sales and revenues, Icelandic company Alvotech lines up a massive capital investment and an initial public offering (IPO).  

Alvotech Lines Up Capital for a Biosimilars IPO

Meir Rinde, MS, is a freelance print and radio journalist based in Philadelphia, Pennsylvania.

The arrival of biosimilars for filgrastim and pegfiltrastim coincided with higher use of granulocyte colony-stimulating factor (G-CSF) for prophylaxis against febrile neutropenia, but many high-risk patients still do not receive the treatment.

Study: High-risk Population Still in Need of G-CSF Biosimilars

A trastuzumab biosimilar candidate demonstrated equivalence to Herceptin in patients with early-stage human epidermal growth factor receptor 2 (HER2)–breast cancer.

EirGenix Trastuzumab Biosimilar Candidate Demonstrates Equivalence in HER2-Positive Breast Cancer

Henlius gains approval in China for Hanbeitai and officials discuss combination therapy options with experimental therapy serplulimab and ophthalmology treatment.

China Regulators Approve Henlius Bevacizumab Biosimilar Hanbeitai

Steven Yates, MD, an oncologist and medical director at Intermountain Healthcare, discusses problems underlying the 340B Drug Pricing Program.

Dr Steven Yates on the 340B Drug Pricing Program

Researchers report findings that suggest a different reimbursement system for Medicare Part B biologics could lead to significantly more robust savings. 

Study: Medicare Consolidated Biosimilar Payment Codes Would Save Money

Regulators are at work clarifying biosimilar guidance and on Capitol Hill, a battle is raging over reforms that could help or hurt biosimilar advancement.

Biosimilars Roundup: November Was Dominated by Legislative and Regulatory News 

Specialty tiers for biosimilars and reforms that address the proliferation of poor-quality patents would help lower costs and improve access, biosimilar industry veterans said.

Biosimilar Industry Critiques Biden's Drug Pricing Reforms

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.

An expert on biotherapeutics recommends more science be applied to World Health Organization (WHO) biosimilar guideline revisions. 

Opinion: One Step Forward, Half a Step Back for WHO Biosimilar Guidance 

Progression-free survival (PFS) was improved for patients with epidermal growth factor receptor–mutated nonsquamous non–small cell lung cancer who were treated with PD-1 and antivascularization therapy.

Oncology