Rituximab biosimilars for lymphoma in Europe

ABSTRACT

Introduction: The approval of rituximab, a monoclonal antibody targeting CD20, revolutionized the treatment of B-cell non-Hodgkin lymphomas and became an undisputed standard of care. However, as with all biologic medicines, the complex development and manufacturing process for rituximab have meant that the medicine attracts high treatment costs. Approved rituximab biosimilars have been comprehensively demonstrated to match the reference medicine. With the potential to increase access to biologic therapy, they have a key role in helping to improve patient outcomes in lymphoma care.

Areas covered: In this review, we discuss the role of rituximab in the treatment of lymphoma. We explore development and regulatory requirements for biosimilar development and the potential impact of these medicines on access and sustainability. Focusing on biosimilars of rituximab, we examine in detail the evidence for biosimilarity for the two rituximab biosimilars that are approved in Europe and provide an overview of rituximab biosimilars currently in development.

Expert opinion: We foresee a wider uptake of biosimilar medicines for lymphoma treatment over the next 5 years. The associated cost savings should be invested in broadening patient access to biological therapies, enabling wider use of more expensive treatment strategies and driving innovation in cancer care.

KEYWORDS:

• Biosimilar
• chronic lymphocytic leukemia
• diffuse large B-cell lymphoma
• extrapolation
• follicular lymphoma
• rituximab
• non-Hodgkin lymphoma

Article highlights

• Biologic therapies are associated with high development and treatment costs, which can result in restrictions in patient access to these therapies.

• Two rituximab biosimilars have been approved for lymphoma treatment, meeting the stringent regulatory guidelines for biosimilar development; these medicines are approved for use in all indications of reference rituximab.

• Several additional biosimilars of rituximab are in development and are likely to be available in the near future.

• Biomimics of rituximab, which are not developed with the same rigor as approved biosimilars, are also available in some countries.

• Increased availability of rituximab biosimilars for the treatment of lymphoma can improve patient access to rituximab treatment and is, in our opinion, expected to result in cost savings and contribute to achieving sustainability of cancer care. Furthermore, improving global access to established biologics, such as rituximab, may also facilitate access to new treatment modalities that are possible with more recently approved drugs.

This box summarizes the key points contained in the article.

Acknowledgments

Under the authors’ direction, medical writing support was provided by Amanda Hatton, MSc of Spirit, a division of Spirit Medical Communications Group Ltd., Manchester, UK, and funded by Sandoz, a Novartis Division.

Declaration of interest

W Jurczak has received research funding from and participated in advisory boards for Celltrion, Roche, and Sandoz. M Długosz Daneka has received research funding from Celltrion, Roche, and Sandoz. C Buske has received consultancy/honoraria from AbbVie, Celgene, Celltrion, Janssen, Pfizer, Roche, and Sandoz. 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 apart from those disclosed.

Reviewer Disclosures

Peer reviewers on this manuscript have no relevant financial relationships or otherwise to disclose.

Correction Statement

This article has been republished with minor changes. These changes do not impact the academic content of the article.

Additional information

Funding

This paper was funded by Sandoz, a Novartis Division.