Biosimilars Watch Time: 33 mins

touchEXPERT OPINIONS Monoclonal antibody biosimilars in the treatment of solid tumours: Perspectives for pharmacists

Find out how monoclonal antibody (MAb) biosimilars are developed and learn about the practical aspects of their use in oncology pharmacy.

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Dr Paul Cornes
Comparative Outcomes Group, Bristol, UK
How similar is a biosimilar? Comparability, interchangeability and extrapolation

Dr Cornes outlines the development and regulatory pathway for biosimilars, and discusses real-world experiences of switching from reference biologics to biosimilars.

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Interview Questions

In this interview, Dr Cornes answers the following questions:

  • What is the consensus on MAb biosimilar use among the oncology community?
  • What is a MAb biosimilar and how does it differ from its reference product?
  • What is the regulatory approval pathway for MAb biosimilars?
  • What can we learn from real-world data on MAb biosimilar use?
  • What can we learn from real-world experience of switching to biosimilars?
  • Why are pharmacists so important?
About Dr Paul Cornes

Paul Cornes is an Oncologist from Bristol, UK. Dr Cornes was part of the steering group for the European School of Oncology Working Party on access to innovation in cancer treatment. read more

He has been involved in two oncology drug advisory committees for biosimilars with the US Food and Drug Administration – including for the first approved US biosimilar. He has been in the British Medical Journal’s Round Table Group on Biosimilars, and has been a faculty member for biosimilars education in meetings including the Drug Information Association, the Royal Pharmaceutical Society and the European Association of Hospital Pharmacists.

Dr Cornes has been on the panel for the European Commission Biosimilars Stakeholders meeting in Brussels and was Chair of the Biosimilars Programme for the World Cancer Congress for the Union for International Cancer Control. In 2020, he wrote the book ‘Fast Facts: Biosimilars in Hematology and Oncology’ with Ali McBride, a US Hospital Pharmacist.

Dr Paul Cornes discloses: honoraria from Accord Healthcare, DuoPharma, European Association for Hospital Pharmacists, European Society of Medical Oncology GI meeting, European Commission, Mylan, Novartis (Sandoz) and Pfizer.

 
Dr Joseph Bubalo
Oregon Health & Science University Hospital & Clinics, Portland, USA
Managing the differences in biosimilar formulations: What are the practical considerations?

Dr Bubalo discusses the formulation and immunogenic potential of MAb biosimilars for the treatment of solid tumours, and overviews management approaches for infusion-related reactions.

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Interview Questions

In this interview, Dr Bubalo answers the following questions:

  • Why are MAb biosimilars not considered generic medicines, if both aim to replicate an originator product?
  • What are the similarities and differences in formulation between MAb biosimilars and reference products?
  • What is the potential for changes in immunogenicity when switching to a MAb biosimilar?
  • What measures can be taken to manage the side effects associated with MAb biosimilar infusions?
About Dr Joseph Bubalo

Dr Joseph Bubalo is an Oncology Clinical Pharmacist with Oregon Health & Science University Hospital & Clinics, Portland and Assistant Professor of Medicine with the Division of Hematology and Medical Oncology. read more

As the Clinical Operations Manager, Dr Bubalo has responsibility for developing, expanding and supporting all clinical activities within the department. He maintains a clinical practice in oncology, while representing the department on many multidisciplinary committees. His administrative interests include improving systems of care, patient safety and clinical pharmacy service development, while his research interests are in supportive care for oncology patients. Supportive care areas or research include antiemetics, infection prophylaxis and treatment, and management of chemotherapy-associated toxicities.

Dr Joseph Bubalo discloses: research support from BTG and Helsinn.

 
Hisanaga Nomura
Japan Agency for Medical Research and Development, Tokyo, Japan
What are the practical challenges associated with ensuring MAb biosimilar stability and appropriate storage and preparation of products?

Mr Nomura describes how handling in the pharmacy affects the stability of MAb biosimilars, and overviews the practical steps for preparing and storing them in the hospital pharmacy.

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Interview Questions

In this interview, Mr Nomura answers the following questions:

  • What is the impact of storage conditions on the stability of MAb biologics for solid tumours?
  • What steps should be taken to ensure the appropriate storage of MAb biologics for solid tumours?
  • What are the practical steps undertaken by the pharmacy team to prepare Mab biologics for parenteral administration in patients with solid tumours?
  • How can hospitals implement best practice for preparing and storing MAb biologics?
About Hisanaga Nomura

Hisanaga Nomura is currently Lead Pharmacist at the Japan Agency for Medical Research and Development. Previously, he was Chief Pharmacist of the outpatient chemotherapy room at National Cancer Center Hospital East. Since 2017, he has been involved with the International Society of Oncology Pharmacy Practice (ISOPP) on the research committee and the Biosimilars Task Force. He has been Secretariat for ISOPP since 2019. read more

Mr Nomura is a board-certified oncology pharmacy specialist at the Japanese Society of Pharmaceutical Health Care and Science. He is Vice Chairman of ‘Guidelines for safe handling of cancer chemotherapy drugs’ in Japan and Director of the Committee on Public Information for the Japanese Society of Pharmaceutical Oncology.

Mr Nomura’s specialization is clinical pharmaceutical care for patients with breast cancer and gastrointestinal cancer.

Mr Hisanaga Nomura has no financial interests/relationships or affiliations to disclose in relation to this activity.

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Overview & Learning Objectives
Overview

In this activity, three leading experts share their insights on using MAbs in oncology practice. Topics include the concepts of comparability, interchangeability and extrapolation, managing variations in biosimilar formulations, and how biosimilars should be handled and stored in the hospital pharmacy.

This activity has been designed to meet the educational needs of pharmacists, oncology pharmacists and hospital pharmacists involved in the clinical screening, preparation and dispensing of MAb biologics for the treatment of solid tumours.

Learning Objectives

After watching this activity, participants should be better able to:

  • Understand the biosimilar concepts of comparability, interchangeability and extrapolation
  • Compare formulations of biosimilars and reference products to inform prescribing choice
  • Appreciate how handling in the pharmacy affects biosimilar and reference product stability
Downloads

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