The biosimilars journey: current status and ongoing challenges

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Biosimilar products are already approved and marketed in several countries. The Food and Drug Administration has approved ten different biosimilars, and the European Medicines Agency has approved 40. Even though this scenario has provided important experience with biosimilar products, there are still challenges and unanswered questions. Up to now, a good amount of knowledge has been gathered in order to support the importance of the totality of evidence and the construction of a biosimilarity exercise for regulatory approval. In addition, the extrapolation of indications has been proved viable when a careful analysis is performed. The models for clinical trials and the use of the most sensible populations have been extensively discussed, and there is apparent homogeneity in manufacturer choices for study designs. However, some challenges remain. The lack of regulatory harmony, especially concerning naming, the marketed intended copies, the interchangeability, and the biosimilars in orphan diseases are some of those and are the focus of discussion in this review.

Keywords: biologics, biosimilars, extrapolation of indications, immunogenicity, interchangeability, rare diseases, switching.

Citation: Kos IA, Azevedo VF, Egg DN, Kowalski SC. The biosimilars journey: current status and ongoing challenges. Drugs in Context 2018; 7: 212543. DOI: 10.7573/dic.212543

Contributions: All authors contributed equally with literature research, writing and reviewing.

Disclosure and potential conflicts of interest: VA has received grant and speaker fees from AbbVie and Pfizer, speaker fees from UCB, Janssen, BMS, and advisory board fees from Pfizer. All the other authors have nothing to declare. The International Committee of Medical Journal Editors (ICMJE) Potential Conflicts of Interests form for the authors are available for download at

Acknowledgments: None.

Funding declaration: There was no funding associated with the preparation of this article.

Copyright: Copyright © 2018 Kos IA, Azevedo VF, Neto DE, Cândido Kowalski S. Published by Drugs in Context under Creative Commons License Deed CC BY NC ND 4.0 which allows anyone to copy, distribute, and transmit the article provided it is properly attributed in the manner specified below. No commercial use without permission.

Correct attribution: Copyright © 2018 Kos IA, Azevedo VF, Neto DE, Cândido Kowalski S. Published by Drugs in Context under Creative Commons License Deed CC BY NC ND 4.0.

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Correspondence: Valderílio Feijó Azevedo, Federal University of Parana and Edumed, Educação em Saúde, Rua Bispo Dom José, 2495 Batel, Curitiba – PR, Brazil, 80440-080.

Provenance: invited; externally peer reviewed.

Submitted: 8 June 2018; Peer review comments to author: 17 August 2018; Revised manuscript received: 27 August 2018; Accepted: 28 August 2018; Publication date: 1 October 2018.

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