The advent of monoclonal antibody (mAb) biosimilars has raised a series of questions in the healthcare community. Just a few of these questions were discussed by Professor Pierre Michetti, a gastroenterologist at the Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland [1].
One question addressed by Professor Michetti was whether the industry had the technical capability to reproduce entire antibodies. He cited the exhaustive and comprehensive comparability exercise conducted to demonstrate the biosimilarity of Celltrion/Hospira’s infliximab biosimilar Remsima/Inflectra (CT-P13) compared to the reference biological (Johnson & Johnson’s rheumatoid arthritis blockbuster Remicade). The comparability exercise met all the stringent requirements requested for European Medicines Agency (EMA) approval and, according to Professor Michetti, ‘clearly showed that nowadays the technology exists to reproduce glycosylated monoclonal antibodies with a high standard of biosimilarity’.
Naming of mAbs was also highlighted as being important in order for ‘patients to know what they receive and in the traceability of the various products’. Professor Michetti concluded that for naming there is no clear answer, as ‘using the same [international non-proprietary name] INN for an originator and its [biosimilars] has advantages as much as drawbacks, while the use of several related INNs poses other problems’. Groups on both sides of the naming debate have given reasons why the same names might cause problems and vice versa how different names might also cause issues [2, 3].
Other questions, which are discussed further in the following two articles, were the extrapolation of indications for mAbs and pharmacovigilance.
Conflict of interest
The author of the research paper [1] has received lecture and consulting fees and grants from pharmaceutical companies. For full details of the author’s conflict of interest, see the research paper [1].
Editor’s comment
Readers interested to learn more about biosimilarity of monoclonal antibody biosimilars are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:
Biosimilarity of anticancer monoclonal antibodies in the clinic
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Related articles
Extrapolation of indications for mAbs
References
1. Michetti P. A Look Beyond the Biosimilarity of the Molecules. J Crohns Colitis. 2016;10(2):123-4.
2. GaBI Online – Generics and Biosimilars Initiative. Biosimilar naming in the US, the debate continues [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Mar 4]. Available from: www.gabionline.net/Biosimilars/General/Biosimilar-naming-in-the-US-the-debate-continues
3. GaBI Online – Generics and Biosimilars Initiative. WHO issues draft proposal for its biological qualifier [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Mar 4]. Available from: www.gabionline.net/Policies-Legislation/WHO-issues-draft-proposal-for-its-biological-qualifier
Source: www.gabionline.net
