GENERICS AND BIOSIMILARS INITIATIVE JOURNAL
Official Journal of the Generics and Biosimilars Initiative
Volume 2 / Year 2013 / Issue 4
Letters to the Editor
Critical immunogenicity differences will be obscured by a common INN for biosimilars
Author(s): Edward T Maggio, PhD
Page: 166Abstract: Information about variable immunogenicity arising from formulation differences between competing biosimilars is critical for informed judgments by prescribing physicians. Use of a common INN for biosimilars will obfuscate such differences to the detriment of patients. Submitted: 31 October 2013; Revised: 12 November 2013; Accepted: 13 November 2013; Published online first: 26 November 2013 Immunogenicity […]
Biosimilars naming and prescribing policy in Australia
Author(s): Brendan Shaw, PhD
Page: 168-9Submitted: 31 October 2013; Revised: 6 November 2013; Accepted: 11 November 2013; Published online first: 25 November 2013 To the Editor: I wanted to bring to your attention the following paper which was published in Volume 2/Year 2013/Issue 3 of the Generics and Biosimilars Initiative Journal. The Perspective paper titled Licensing and prescribing biosimilars in […]
Legislative efforts to limit prescription information sharing between patients and healthcare providers represent a serious threat to the health and safety of the American nation
Author(s): Janet S Wyatt, RN, PhD, FAANP
Page: 165Abstract: Legislation in support of pharmacist notification to patients and providers of substitution of an interchangeable biologic for the originator biologic was recently vetoed in California. Automatic substitution of approved biosimilars without notifying the patient and physician/healthcare provider circumvents important pharmacovigilance. Submitted: 21 October 2013; Revised: 22 October 2013; Accepted: 25 October 2013; Published online […]
WHO leadership in public safety on biosimilars to be commended
Author(s): Richard O Dolinar, MD
Page: 167Abstract: As a practicing endocrinologist and Chairman of the Alliance for Safe Biologic Medicines, I am writing to commend the World Health Organization for its attention to and upcoming action on the important issue of non-proprietary names for biotech medicines. Submitted: 20 September 2013; Revised: 21 September 2013; Accepted: 21 September 2013; Published online first: […]
