Biosimilars in Cancer Care: Challenges and opportunities for Health Professionals and Patients

Chairs: M. Aapro, CH - G. Curigliano, IT


FOREWORD
Over the past two decades, the United States and Europe experienced a dramatic and unsustainable rise in cancer health care costs. Eight of the top ten most expensive drugs are cancer drugs, notably the novel biologic agents arising out of the recent revolution in our understanding of the genetic and molecular basis of malignancy. As the protective patents on new biologic therapies reach expiration, the race to develop biosimilars has begun, hopefully increasing competition and reducing costs. Although authorities have developed regulations for the development and approval of biosimilars, it remains uncertain how rapid and broad their entry will be. The reasons for such uncertainty are multiple but fundamentally relate to the biologic nature of these agents: these drugs, unlike generic pharmaceuticals, are large, complex molecules derived from biologic processes that are similar but not identical to the original agent and, thus, subject to immunogenicity and drift over time. The demonstration of comparable efficacy and safety to the originator is a challenge for both regulators and companies, necessitating careful pharmacovigilance following approval.

LEARNING OBJECTIVES
• Explain the importance of analytical studies in development and regulatory approval of biosimilars.
• Describe the concepts of immunogenicity and extrapolation of indications based on evaluation of the totality of the evidence and mechanism of action rationale.
• Appraise the importance of pharmacoeconomics and access to biological oncology medicines in Europe.
• Discuss the potential clinician-, nurse-, pharmacist-, and patient-specific issues relating to the suboptimal use of biosimilars and strategies to mitigate them.
• Summarize current and emerging data on oncology monoclonal antibody biosimilars and their potential to enable optimal combination therapy.

TARGET AUDIENCE
This educational initiative is directed toward oncology health care practitioners including medical oncologists, surgical oncologists, radiation oncologists, pharmacists, patient advocates and nurses, involved or interested in treatment of cancers. The enduring components of this educational initiative are targeted to the broader audience of European pharmacists and physicians.

FACULTY
M. Aapro, IMO Clinique De Genolier, Institut Multidisciplinaire d'Oncologie, Genolier, CH
G. Curigliano, European Institute of Oncology, Milan, IT
P. Declerck, KU Leuven, Leuven, BE
M. Dicato, Centre Hospitalier de Luxembourg, LU
M. Dougherty, United States Food and Drug administration, FDA, Silver Spring, MD, US
A. Eniu, Cancer Institute "Ion Chiricuta", Cluj-Napoca, RO
R. Giuliani, Azienda Ospedaliera San Camillo - Forlanini, Roma, IT
D. Meani, Rotkreuz, CH
X. Pivot, Centre Hospitalier Jean Minjoz, Besançon, FR
H. Rugo, University of California San Francisco, USA
A. Stathis, Oncology Institute of Southern Switzerland, Bellinzona, CH
H. Schellekens, Utrecht University, Utrecht, NL
D. Trapani, European Institute of Oncology, Milan, IT
E. Wolff-Holz, Paul Ehrlich Institut, Langen, DE
N. Zernik, Europa Donna, Paris, FR

ORGANISING SECRETARIAT
European School of Oncology (ESO)
Bellinzona Office
Piazza Indipendenza, 2
6500 Bellinzona - Switzerland

Programme and Organisation
Laura Richetti
lrichetti@eso.net - Tel: +41 91 820 09 51

Registrations, Sponsorship and Travel grants:
Luis Carvalho
lcarvalho@eso.net - Tel: +41 91 820 09 58

OFFICIAL LANGUAGE
The official language will be English. No translation will be provided.

INSURANCE
The organisers bear no responsibility for untoward events in relation to the participation in the Conference. Participants are advised to take out their own personal and travel insurance.

VENUE
Crowne Plaza Barcelona
Fira Center, Av. Rius i Taulet, 1-3
Barcelona
Spain
www.crowneplaza.com/barcelonafira

CME ACCREDITATION AND CERTIFICATES
All participants will be able to print their own certificate on the completion of the online evaluation form.
The event has been accredited by the European Accreditation Council for Continuing Medical Education (EACCME) to provide the following CME activity for medical specialists. The EACCME is an institution of the European Union of Medical Specialists (UEMS). The evaluation of the event has been performed by the Accreditation Council of Oncology in Europe (ACOE) that acknowledged the quality of the scientific programme and its educational value. The event is designated for a maximum of 7 European CME credits (ECMEC). Through an agreement between UEMS and the American Medical Association, physicians may convert EACCME credits to an equivalent number of AMA PRA Category 1 Credits™.

REGISTRATION DESK, OPENING HOURS
Friday, 16 November 10:00-17:30
Saturday, 17 November 8:00-12:30

SPONSORS
ESO wishes to express its appreciation to the following sponsors for having granted their participation and support to conference:

REGISTRATION
Registration can only be carried out onsite at the registration desk on Friday, 16 November 2018 (starting from 10:00).
Registration grants participantion in all sessions, coffee breaks and lunch as indicated in the programme.
All rates are quoted in Euro and include VAT.

NURSES AND PATIENT ADVOCATES
Nurses and representatives of cancer patient advocacy non-profit organisations are eligible for a discounted registration fee:

- Euro 200 by 26 August 2018
- Euro 250 by 4 November 2018
- Euro 300 from 5 November and on-site

To register to the Conference, nurses and representatives of patient advocacy organisations should submit the following documents within the deadline:

• Nurses: curriculum vitae with full contact details
• Patient advocates: curriculum vitae or resume indicating the advocacy experience, role within the organisation and the full contact details of the patient advocate organisation

Interested nurses and patient advocates should contact Luis Carvalho (lcarvalho@eso.net) in order to register to the conference.

MEDIA REGISTRATION
The Conference is open to representatives of print and electronic media, if interested, please contact  lcarvalho@eso.net.

CANCELLATION OF REGISTRATION OR REPLACEMENT
Cancellation should be notified to ESO in writing. In case of cancellation without replacement, the fee less handling charges of EUR 100 will be refunded after the event, provided that the cancellation is recived by ESO before 26 August 2018. Replacements will be possible till 26 of August 2018.

CONFIRMATION OF REGISTRATION
Registration will be confirmed by e-mail.

BADGE
The badge is the only official evidence of registration and should be worn at all
times during the event. Loss of badge causes loss of registration.