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Interchangeability of biosimilars: a global perspective for pharmacists


Professor Ramzan does a very good job of summarizing an emerging and important concept in medicines-use, namely the interchangeability of biosimilars. While careful readers of the entire text of this article will get a good understanding of this issue, a casual review including the title and key points may mislead the reader on few points. • The use of the word “interchangeable” in the title and key points implies that biosimilars are interchangeable with the reference product. It does not say this in the text, but some readers may be misled if they only read the key points. In the US, the FDA has a separate and specific category for interchangeable biosimilars, though none have been designated as such to date. • Under the topic of naming, the issue of non-proprietary naming is not mentioned. Distinguishable names are required by the FDA in the US, and there are varied practices in other countries, with an effort to harmonize naming globally through the Biologic Qualifier proposal at WHO. • The importance of pharmacovigilance and post-marketing surveillance is discussed but the limitations of the current systems is not. For example, many of these systems lack the complete information needed to associate the exact drug with the event being reported. Indeed 5% of ADR reports for infliximab products in EU during 2018 did not include brand name despite it being required by law since 2012. (source: EMA EudraVigilance database of ADR reports.) • The recommendation that “Pharmacists should provide advice on biosimilars to prescribers…” assumes the they are not knowledgeable about them. There are good data showing that physicians the actually use biosimilars are now pretty familiar with them. A recent survey conducted by the Alliance for Safe Biologics found that the percentage of physicians who rate themselves as being “familiar” or “very familiar” with biosimilars has increased from 76% in 2013 to 90% in 2019. This is reflected by their willingness to prescribe biosimilars to bio-naive/new patients. A strong majority (84%) of physicians are comfortable prescribing biosimilars to treatment-naïve patients. Comfort level decreases to 60% when asked about switching a stable patient to a biosimilar. While only 17% are uncomfortable in prescribing a biosimilar to a naïve patient; more than twice as many (40%) are uncomfortable with switching a stable patient to a biosimilar. Given the concern over the rising cost of healthcare due in part to the increasing use of expensive but valuable biologic medicines, pharmacists do need to take a leadership role in managing costs, without risking problems with effectiveness and safety. Collaboration with prescribers is critical in assuming this role so that formulary and payment policies do not compromise the accountability and responsibility health care professionals – including pharmacists - have for their patients. Philip J. Schneider, MS, FASHP, FASPEN, FFIP Chairman, International Advisory Board, Alliance for Safe Biologic Medicines Professor, College of Pharmacy, The Ohio State University

Posted date

21 SEP 2020

Posted time



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