GENERICS AND BIOSIMILARS INITIATIVE JOURNAL
Official Journal of the Generics and Biosimilars Initiative
Volume 2 / Year 2013 / Issue 3
Review Article
Steps to ensure adequate supply of biological medicines: considerations for the healthcare provider
Author(s): Andrew Mica, MBA, et al.
Page: 136-43Author byline as per print journal: Andrew Mica, MBA, Martha Mutomba, PhD, Larry Green, PharmD Introduction: When drug shortages occur, healthcare providers (HCPs) often must ration drugs, cancel or delay treatments, or utilize alternative drugs that may be less efficacious and/or are associated with increased risk of adverse outcomes, potentially impacting patient care. The likelihood […]
Safety and toxicity of biosimilars—EU versus US regulation
Author(s): Angela Vogt-Eisele, PhD, Professor Marietta Kaszkin-Bettag, PhD, Tilo Netzer, PhD, Wolfram Hildebrandt, MSc, MA, Tobias Blank, PhD
Page: 144-50Author byline as per print journal: Tobias Blank, PhD, Tilo Netzer, PhD, Wolfram Hildebrandt, MSc, MA, Angela Vogt-Eisele, PhD, Professor Marietta Kaszkin-Bettag, PhD Background: As patents for biological drugs begin to expire, the need for scientific guidance on biosimilar drugs grows increasingly important. The European Medicines Agency provided the first guidelines to cover the approval […]
