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Clinical

Tahir Amin, Dip LP, co-executive director of I-MAK, discusses some hot-button issues regarding the US patent system, including AbbVie’s alleged abuse of it, and his hopes for improvement.

Activist Lawyer Discusses AbbVie and Patent System Shortcomings

Ping Cao, vice president of Business Development for Shanghai Henlius Biotech, discussed the company's current biosimilar development plans and the process for getting regulatory approval for biosimilars in China.

Not So Different: How Henlius is Making Its Mark on the Global Biosimilar Industry

Sophia Z. Humphreys, PharmD, MHA, is the director of System Pharmacy Clinical Services for Providence St. Joseph Health (PSJH), a multistate hospital system based in Renton, Washington. She has nearly 20 years of specialized experience in the pharmaceutical industry and is an expert in pharmacy regulatory compliance, US Pharmacopeia General Chapter <797>/<800> pharmacy regulations, clinical education, long-term care pharmacy service, and pharmaceutical waste management. She has a strong background in strategic planning and project management. Prior to her current position, she served as the PSJH drug information manager.

Sophia Z. Humphreys, PharmD, MHA, explains how biosimilar utilization management can enable health care institutions to put COVID-19–related financial wreckage behind them.

Opinion: Biosimilars Can Aid in Post–COVID-19 Health Care Financial Recovery

Meaghan Smith is the executive director of the Biosimilars Forum. She previously served as a senior adviser and communications director at HHS during the Obama administration.

In this column, officials from the Biosimilars Forum and Xcenda discuss how biosimilar competition has lowered prices of originator biologics and improved patient access.

Opinion: Biosimilars Offer Savings and Access for US Patients

Reverse switching occurs when patients transitioned to or initiated on a biosimilar are changed to an originator product, often because of a perceived failure in the biosimilar therapy.

Poll: Identify the Main Cause for Reverse Switching

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, a member of The Center for Biosimilars® Advisory Board, reports on his citizen petition to the FDA to rationalize testing of biosimilars. 

Opinion: A Rational Approach to Establish Biosimilarity

Tony Hagen is senior managing editor for The Center for Biosimilars

Biosimilar manufacturers may encounter roadblocks in the months and years ahead, and generics manufacturers will find they've hit a ceiling, according to Adam Fein, PhD, CEO of the Drug Channels Institute.

Pharmacy Economist Describes Fork in the Road for Generics and Biosimilars

The anatomy of an interchangeability switching study. 

The Difference Between an Interchangeable Biosimilar and One That Isn't

How much muscle did Congress invest in a pair of bills recently signed by President Biden? The answer may lie in your willingness to believe. 

Toothful or Toothless? Biden's Biosimilar Bills Under the Microscope

Medicinal packaging shouldn't remind patients that they have a condition, according to Samsung Bioepis.

Dermatology