Biosimilars: The Need, The Challenge, The Future: The FDA Perspective

The US Approach to Biosimilars

(2013) Begoña Calvo et al.   BIODRUGS

How the FDA Manages Drug Safety With Black Box Warnings, Use Restrictions and Drug Removal, With Attention to Gastrointestinal Medications

(2012) Eli D Ehrenpreis et al.   AMERICAN JOURNAL OF GASTROENTEROLOGY

Biosimilars: Impact of Biologic Product Life Cycle and European Experience on the Regulatory Trajectory in the United States

(2012) Islah Ahmed et al.   CLINICAL THERAPEUTICS

Biosimilars and biobetters as tools for understanding and mitigating the immunogenicity of biotherapeutics

(2012) Maria D.F.S. Barbosa et al.   DRUG DISCOVERY TODAY

Biosimilar insulins

(2012) Lutz Heinemann   EXPERT OPINION ON BIOLOGICAL THERAPY

Analytical tools for characterizing biopharmaceuticals and the implications for biosimilars

(2012) Steven A. Berkowitz et al.   NATURE REVIEWS DRUG DISCOVERY

Risk management of biosimilars in oncology: each medicine is a work in progress

(2012) Arnold G. Vulto et al.   Targeted Oncology

The FDA's Generic-Drug Approval Process: Similarities to and Differences From Brand-Name Drugs

(2011) Costas H Kefalas et al.   AMERICAN JOURNAL OF GASTROENTEROLOGY

What's fueling the biotech engine—2009–2010

(2010) Saurabh Aggarwal   NATURE BIOTECHNOLOGY