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Poster display session

5467 - Oncologists ’ perspectives on biologic substitution


10 Sep 2017


Poster display session


Cancers in Adolescents and Young Adults (AYA);  Bioethical Principles and GCP


Michael Reilly


Annals of Oncology (2017) 28 (suppl_5): v511-v520. 10.1093/annonc/mdx385


M. Reilly1, A. Spiegel2

Author affiliations

  • 1 Executive Office, Alliance for Safe Biologic Medicines, 22203 - Washington DC/US
  • 2 Executive Office, Global Colon Cancer Alliance, Bala Cynwyd/US


Abstract 5467


Biosimilars are similar but not identical to originator biologics. As more biosimilars are approved, pharmacy or hospital-level substitution of biologics is becoming more common, potentially excluding physicians from decisions regarding the treatment of their patients.


The Alliance for Safe Biologic Medicines (ASBM) conducted regional, 15-minute web-based surveys among biologics prescribers around the world to determine their opinions on biologic substitution. Prescribers were asked to rate: (1) the importance of authority to decide the most suitable biologic for their patients, (2) the importance of designating a biologic as “dispense as written” (DAW, or equivalent), (3) the acceptability of biologic substitution, and (4) the importance of notification of biologic substitution.


A total of 1,856 responses were received: 470 (25%) Europe, 427 (23%) Canada, 400 (22%) US, 399 (21%) Latin America, and 160 (8.6%) Australia. Across regions, most prescribers were from the hospital setting, and most had ≥ 11 years in practice. Between 10% and 25% of prescribers were oncologists (16% Europe, 10% Canada, 16% US, 18% Latin America, and 25% Australia). Across regions, most oncologists (75%) feel that it is critically/very important to have sole decision-making authority regarding the suitability of a biologic, and 71% that it is critically/very important to have DAW authority. Only 6% of oncologists feel that pharmacy-level substitution is totally acceptable; 58% consider switching to a biosimilar unacceptable, and 36% consider switching acceptable provided it has been agreed to in advance. Most (76%) also feel that it is critically/very important to be notified of pharmacy-level substitution. Responses were mostly aligned across regions; however, one notable difference was the relatively low percentage of Australian oncologists (23% vs 58% overall) who feel that substitution is unacceptable.


Our survey indicates that most oncologists believe it is important for them to be able to control which biologic—original product vs biosimilar—they prescribe for their patients. This is likely to become increasingly important with the availability of biosimilars used for curative intent.

Clinical trial identification

Legal entity responsible for the study

Alliance for Safe Biologic Medicines


Amgen and AbbVie


M. Reilly: Funding from Amgen and AbbVie Inc.


A. Spiegel: Funding from BIO, PhRMA, Amgen, Roche, EMD Serano.


M. Reilly: Funding from Amgen and AbbVie Inc.

A. Spiegel: Funding from BIO, PhRMA, Amgen, Roche, EMD Serano.

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