Biosimilar epoetin zeta: extrapolation of indications and real world utilization experience

ABSTRACT

Introduction: There is an essential need for clinicians to understand the development and approval process of biosimilars. Extrapolation of efficacy and safety data from one indication to another may be considered by a comprehensive comparability program including safety, efficacy and immunogenicity, which detect potentially clinically relevant differences.

Areas covered: This article specifically discusses the approval of epoetin zeta (Retacrit™, Hospira, a Pfizer company) and the EMA reasoning for extrapolation of indications. Additionally, the results of the ongoing utilization surveillance program that was approved in 2007 and has analyzed over 120 million patient days of epoetin zeta treatment are presented.

Expert opinion: At the time of approval, uncertainty of safety and efficacy is much less for biosimilars than for new innovative products. Approval of indications based on extrapolation of data is based on sound and objective scientific criteria and a logical consequence of the biosimilar concept that has been successfully implemented in the European Union.

Biosimilar epoetin has been used extensively in patients in Europe for nine years. Following a review of the known risks and ADR information received in almost 120 million patient-days’ worth of experience, the risks associated with treatment with epoetin zeta remain similar to those of the reference product.

KEYWORDS:

• Biosimilars
• Retacrit
• epoetin
• extrapolation
• post-marketing surveillance
• EPAR

Declaration of interest

T Dingermann has received honoraria for oral presentation from Hospira, a Pfizer company, Mundipharma, Teva, Progenerika, EGA/European generic medicines association. Not relevant to the article, but in the interest of full disclosure, the author declares that in the past he has also received honoraria for oral presentation from the following Biotech companies: Amgen, AbbVie, Genzyme, Merck-Serono, Novo-Nordisk, Roche, Sanofi, Stada, and Pfizer. F Scotte has received honoraria for oral presentation from Hospira, a Pfizer company, Teva, Roche, Amgen, Pierre Fabre Oncology, Sanofi, Vifor pharma, Merck-Serono, Merck, Norgine. Not relevant to the article, but in the interest of full disclosure, the author declares that in the past he has also received honoraria for consultancy from the following Biotech companies: Roche, Hospira, a Pfizer company, Pierre Fabre Oncology, Merck, Leo Pharma. Editorial assistance was provided by Anne Gentry, PharmD, (Gentry Medical Communications, LLC) supported by Hospira, a Pfizer company. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.