Linked to EAHP Statements

Section 1 - Introductory Statements and Governance: Statements 1.1, 1.6
Section 4 - Clinical Pharmacy Services: Statement 4.1

ACPE UAN: 0475-0000-19-007-L01-P. A knowledge based activity.

Abstract

For many years, biological drugs have not been subject to competition by generics. There are good reasons for this, as complex biological molecules cannot be shown to be bioequivalent based solely on analytical data and pharmacokinetic studies.

Drug regulatory authorities acknowledged this, and the European Union (EU) pioneered the concept of biosimilars with detailed guidance to show bioequivalence of biological drugs. This concept has been applied for several medicinal products, such as growth hormone, epoietin or granulocyte colony stimulating factors, and more recently, monoclonal antibodies (infliximab) and a fusion protein (etanercept). In all cases, there are no reports of efficacy or safety concerns, and biosimilar use is now widespread in many countries.

This is now also an issue in the treatment of hematologic cancers, especially Non-Hodgkin Lymphoma. Since the beginning of this century, rituximab changes the disease. Patients live longer with a better quality of life, and with better survival rates, but the cost has been very high. A Biosimilar of rituximab is coming to market. The opportunity for savings is huge. On the other hand, this drug is so important that this may lead to some concerns, especially regarding extrapolation of data from small-scale biosimilar clinical trials. To complicate matters further, major innovation companies are coming to the market with new drugs to replace rituximab, and this may prove to be an expensive and not always useful option.

To make the best of this new frontier, hospital pharmacists must understand the concepts and facts, to be able to provide a scientific unbiased approach to this issue, with a focus on patient care in a world of limited resources.

Learning objectives

After this Synergy session, participants should be able to:

• acquire new understanding of the key facts which support biosimilar approval in the EU as applied to onco-haematology therapy;
• recognise biased trends of change in first line therapy;
• advise as how to implement biosimilar of monoclonal antibodies used in Non-Hodgkin Lymphoma and other hematologic diseases.

Educational need addressed

The recent availability of rituximab biosimilars drives a need for specific knowledge on the quality and clinical background of the approval process, and also of the role of biosimilars in budget management in haemato-oncology setting, considering all the new therapeutic options available for these diseases. This is mostly relevant for all pharmacists involved in oncology, as they will likely be questioned by other healthcare professionals, management or even by patients.