Biosimilars: An Opportunity to Update the Product Information of Biological Drugs Regarding their Immunogenicity
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One of the greatest theoretical clinical concerns regarding the development of biosimilars has been that post-translational protein modifications, even while antigen binding remains essentially unaltered, might result in detrimental immunogenicity. We recently published an article in BioDrugs  that demonstrated that the Summary of Product Characteristics (SmPCs) of biological drugs, approved by the European Medicines Agency (EMA), are very heterogeneous regarding the issues related to immunogenicity that are addressed within these documents. A complementary analysis, using the methodology advanced in our article , to the EMA’s “Procedural Steps Taken and Scientific Information After the Authorisation” documents shows that 57% (39/69) of the biological drugs that have been authorized prior to 2012 did not update their SmPC at least once when it comes to information related to unwanted immunogenicity. These are surprising results given the advancements that have been seen in the...
All authors meet the journal’s criteria for authorship. All authors have contributed to the work and approve the presented findings.
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No sources of funding were used to support the writing of this letter.
Conflict of interest
PT has received research grants or has been an invited speaker and advisor for AbbVie, Biogen, Celgene, Fresenius Kabi, Galapagos, Gilead, GSK, Janssen, Lilly, Novartis, Pfizer, Roche, Sandoz, Sanofi, and UCB. JG has received research grants or has been an invited speaker and advisor for Biogen, Astra-Zeneca, Pfizer, Sandoz, Novartis, and Hikma. RB and JPC have no conflicts of interest to declare.
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