Biosimilars – terms of use

Abstract

The impending expiry of the patent on a number of leading biologic drugs has led to a surge in the development of ‘biosimilar’ or ‘follow-on’ products. However, in contrast to generic small-molecule medicines, biosimilars are not identical to their reference products. The differences and complexities surrounding both the molecular structure and the manufacturing process for biologics and biosimilars have resulted in a lack of clarity regarding the terms used in different parts of the world to define various aspects of development and utilization such as regulatory approval, pharmacovigilance, interchangeability and treatment-naivety. This makes quantitative evaluation of biosimilars a great challenge to both the scientific community and regulatory agencies.

 This manuscript attempts to clarify the terms used and address an important knowledge gap which is currently resulting in an increasing rush to position biosimilars for certain indications and patients in the absence of agreed upon definitions.

Keywords: :

• Biologics
• Biosimilars
• Interchangeability
• Pharmacovigilance

Transparency

Declaration of funding

This publication was sponsored by Amgen who provided financial support for editorial assistance to the authors. The authors did not receive any personal financial support from Amgen and the funding for writing assistance had no influence on the content of the article or the decision to submit it for publication.

Declaration of financial/other relationships

P.D. has disclosed that he is a consultant to AbbVie, Amgen and Hospira; and is on the Speakers’ Bureau of AbbVie, Celltrion, Hospira, Merck Serono, and Roche. H.M. has disclosed that he is a consultant to Amgen, Hospira and Roche; and is on the Speakers’ Bureau of Prime Oncology. S.D. has disclosed that he is a consultant to and is on the Speakers’ Bureau of the following: Abbott Labs, AbbVie, Merck & Co., UCB Pharma, Ferring, Cellerix, Celltrion, Millenium Takeda, Nycomed, Pharmacosmos, Actelion, Alfa Wasserman, Genentech, Grunenthal, Pfizer, AstraZeneca, Novo Nordisk, Cosmos Pharmaceuticals, Tigenix, Vifor and Johnson & Johnson.

CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgments

The authors thank Diane Rees who provided medical writing support for the preparation of this article.