Assessment of Pharmacists’ Views on Biosimilar Naming Conventions

Fernandez-Lopez, Sara; Kazzaz, Denise; Bashir, Mohammed; McLaughlin, Trent

doi:10.18553/jmcp.2015.21.3.188

Cited by 14 publications

(21 citation statements)

References 2 publications

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“…New and shorter target substems were adopted in 2009 [39]. They generally consist of a consonant, plus a vowel which is omitted if the source substem begins with a vowel.…”

Section: Naming Of Monoclonal Antibodies and Biosimilarsmentioning

confidence: 99%

A Primer on Biosimilars: FDA-Approved and those in the Pipeline

Pillai¹,

Malcom²,

Cox³

2017

SOJPPS

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Biologics have made groundbreaking treatments possible, for several difficult to treat conditions. However, they are very expensive, and biosimilars are expected to push prices down like the generics of small molecule drugs did in the past, replacing more costly brandname drugs. Biosimilars are not just generic replacement for brand name biologics, and their effect on cost reduction will be much more modest. Biologics, made from living organisms, are much larger in size and complex molecules than small molecule drugs which are easily synthesized, characterized and copied. Biosimilars may be highly similar to the original licensed biologic product but not a fingerprint copy; therefore, some differences are expected. This article describes the criteria for establishing similarity and interchangeability, current regulations and the clinical and pharmacoeconomic aspects of the four FDA approved biosimilars in 2015 and 2016.

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“…New and shorter target substems were adopted in 2009 [39]. They generally consist of a consonant, plus a vowel which is omitted if the source substem begins with a vowel.…”

Section: Naming Of Monoclonal Antibodies and Biosimilarsmentioning

confidence: 99%

A Primer on Biosimilars: FDA-Approved and those in the Pipeline

Pillai¹,

Malcom²,

Cox³

2017

SOJPPS

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“…A fourth option is to use the branded name of the drug. A fifth option is to use the same INN once comparability and interchangeability have been demonstrated [28].…”

Section: Global Biosimilar Naming Conventionsmentioning

confidence: 99%

“…use of the same INN for biosimilars, suggest that any other naming convention may result in less automatic substitution for interchangeable biologics [28]. Owens et al [29] demonstrated that more than 76 % of prescribers assume that drugs with the same INN are structurally identical.…”

Section: Global Biosimilar Naming Conventionsmentioning

confidence: 99%

“…Owens et al [29] demonstrated that more than 76 % of prescribers assume that drugs with the same INN are structurally identical. Fernandez-Lopez et al [28] determined that pharmacists are more confident about substituting interchangeable biologics when both the originator biologic and the biosimilar share the same INN. Advocates instead suggest relying on brand names, lot numbers and national drug codes (NDCs) to track safety, as well as enhancements in education and technology tracking safety [28,30].…”

Section: Global Biosimilar Naming Conventionsmentioning

confidence: 99%

“…are prescribed by brand name, such as insulin) are not always attributed to a manufacturer correctly. A recent survey conducted by Xcenda indicated that in the USA, pharmacists currently identify biologics by NDC number [28]. This option could be viable; however, the FDA does not require that the NDC number appear on all drug labels [39].…”

Section: Conclusion and Reflectionsmentioning

confidence: 99%

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Evaluating AE Reporting of Two Off-Patent Biologics to Inform Future Biosimilar Naming and Reporting Practices

Stergiopoulos

Getz

2015

Drug Saf

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Historical studies of voluntary, spontaneous drug reports show poor attribution of adverse events to generic versions of commonly prescribed medications. As biosimilars enter the market place, it may be similarly difficult to accurately attribute adverse events to their respective reference products. At this time, lack of global consensus with regard to biosimilar naming conventions may result in drug reporting confusion, misattribution of adverse events and insufficient active monitoring of safety signals. Now, with the first biosimilar approval in the USA and many biosimilars expected to be launched globally in the near future, US Food and Drug Administration (FDA) guidance on biosimilar naming conventions will be essential. To inform the FDA and the global drug development community, the Tufts Center for the Study of Drug Development (Tufts CSDD) examined primary suspect reports sent to the FDA's Adverse Event Reporting System (FAERS) from US reporters for two biologics that have lost patent exclusivity-somatropin and human insulin-and extracted 4703 insulin reports and 6487 somatropin reports from FAERS. The results show that reporting practices are inconsistent between the two biologics that were evaluated and that manufacturer identifiability and traceability are lacking. Ways to improve biosimilar naming conventions and improve reporting practices are suggested. Key PointsDespite strong expected growth in biosimilar approvals over the next decade, there is no global harmonization on biosimilar interchangeability and nomenclature at this time.The US Food and Drug Administration is now considering a number of naming convention options that may facilitate global harmonization.A retrospective study of two off-patent biologics suggests that manufacturer identifiability and traceability are lacking and that better naming conventions are needed to ensure public safety.

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Capture of biologic and biosimilar dispensings in a consortium of U.S.‐based claims databases: Utilization of national drug codes and Healthcare Common Procedure Coding System modifiers in medical claims

Zhang

Haynes

Mendelsohn

et al. 2019

Pharmacoepidemiology and Drug

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To assess the capture of biologics (originator and biosimilar) in the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) Distributed Research Network (DRN), with a focus on medical claim National Drug Code (NDC), a new data field, and Healthcare Common Procedure Coding System (HCPCS) modifier. Methods: We conducted a repeated cross-sectional study among patients with medical and pharmacy benefits enrolled in insurance plans participating in the BBCIC DRN between 1 January 2013 and 30 September 2017. We calculated the proportion of medical claims with ≥1 NDC and identified select biologics using four different approaches: (a) specific HCPCS alone, (b) specific HCPCS and NDC, (c) nonspecific HCPCS with NDC, and (d) HCPCS with modifiers (applicable to biosimilars). Numbers of dispensings were calculated for each biologic by approach and select patient and claim characteristics. Results: More than 1.5 million eligible participants contributed approximately 4 million person-years of data, including 1.2 billion medical claims. The proportion of medical claims with ≥1 NDC increased from 1.2% in 2013 to 3.0% in 2017. Medical claim NDCs identified 39% and 28% of vedolizumab dispensed in 2014 and 2015 and 30% of Epogen/Procrit dispensed overall. Out of 26,381 filgrastim biosimilar dispensings identified, 51% had a HCPCS modifier and 12% had a medical claim NDC for Zarxio. HCPCS modifiers and medical claim NDCs were present for 38% and 3% of all infliximab biosimilars dispensed (total n = 1,244). Conclusions: Medical claim NDC and HCPCS modifier improves identification of select biologics without product-specific HCPCS code, thereby facilitating productspecific biologic research. The contents of the manuscript have been presented as a poster at the 2019 AMCP Managed Care and Specialty Pharmacy Annual Meeting 2019. The research was sponsored by the Biologic and Biosimilars Collective Intelligence Consortium (BBCIC), a nonprofit, scientific public service initiative.

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Assessment of Pharmacists’ Views on Biosimilar Naming Conventions

Abstract: BACKGROUND: As the date for the introduction of biosimilars in the United States approaches, questions remain regarding the naming, coding, and approval process for these agents that will need to be carefully considered.

Cited by 14 publications

References 2 publications

A Primer on Biosimilars: FDA-Approved and those in the Pipeline

A Primer on Biosimilars: FDA-Approved and those in the Pipeline

Evaluating AE Reporting of Two Off-Patent Biologics to Inform Future Biosimilar Naming and Reporting Practices

Capture of biologic and biosimilar dispensings in a consortium of U.S.‐based claims databases: Utilization of national drug codes and Healthcare Common Procedure Coding System modifiers in medical claims

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