Pharmacovigilance for mAbs

Pharmacovigilance could be the biggest challenge in the use of mAbs, according to Professor Michetti.  He believes that ‘the arrival of the first mAb in the large field of immune-mediated inflammatory diseases (IMID) will probably affect the overall use of biologicals in these indications, far beyond its originator, to the other anti-TNF agents and even to biologicals with other mechanisms of action’. This is based on the fact that ‘in the absence of direct comparison trials among biologicals, there is no evidence to support the use of one biological over the others in most indications’.

Professor Michetti adds that if one compound, e.g. biosimilar infliximab, becomes much less expensive it might become difficult for physicians to make cost-independent choices, especially if switching to infliximab biosimilars is made practically mandatory by large tender systems. The presence of a less expensive infliximab biosimilar will therefore also put price pressure on the other anti-TNFs.

Such price pressure Professor Michetti believes will translate into ‘an increased number of manufacturing changes, number which will grow with the number of players and with the market expansion that lower prices will certainly also induce’. Each manufacturing change carries a risk of introducing an unwanted alteration in the molecule and could have a clinical impact on efficacy or in safety, highlighting the need for all physicians to participate in pharmacovigilance efforts. Professor Michetti cites the case of a problem after the introduction of erythropoietin biosimilars as an example of such pressure. It should however be pointed out that this incident of pure red cell aplasia occurred in the originator epoetin alfa Eprex [2].

Several large pharmacovigilance databases are already available and disease-specific banks at both national and international levels are under development for this purpose.

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 biosimilar monoclonal antibodies in Europe are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:

Biosimilar monoclonal antibodies—challenges and opportunities in Europe

Readers interested in contributing a research or perspective paper to GaBI Journal – an independent, peer reviewed academic journal – please send us your submission here.

Related articles
Extrapolation of indications for mAbs

Beyond biosimilarity

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. Epoetin alfa and pure red cell aplasia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Mar 18]. Available from: www.gabionline.net/Biosimilars/Research/Epoetin-alfa-and-pure-red-cell-aplasia