Developing the Nation's Biosimilars Program

Kozlowski, Steven; Woodcock, Janet; Midthun, Karen; Sherman, Rachel Behrman

doi:10.1056/nejmp1107285

Cited by 178 publications

(148 citation statements)

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“…To date, the FDA has not issued any guidance on interchangeability and indicated that it will "develop standards to ensure that products not deemed interchangeable are not inadvertently substituted for a reference product without the prescriber's consent." 22 Toward this goal, the FDA recently published the "Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations," nicknamed the Purple Book, which intends to be analogous to the Orange Book for generic products. 23 The publication lists biosimilar agents (and whether they have been deemed to be interchangeable) and their corresponding reference product, as well as information regarding a biologic's licensure pathway and exclusivity status.…”

Section: ■■ Considerations For Interchangeable Biosimilar Substitutionmentioning

confidence: 99%

Pharmacist Substitution of Biological Products: Issues and Considerations

Ramanan²,

Green³

2015

JMCP

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SUMMARYBiosimilars are biological products that are highly similar to their biological reference products, notwithstanding minor differences in clinically inactive components. However, unlike generics of small-molecule drugs, biosimilars are not identical to their reference products, since each manufacturer uses unique cell lines and processes, and these lead to slight structural differences between products. Because these structural variations can lead to differences in clinical response, clinical studies demonstrating biosimilarity are required before and robust pharmacovigilance after approval. Although the FDA has not yet issued formal guidance on interchangeable biosimilars, higher standards of similarity will be required in order to achieve an interchangeable designation. In this commentary, we review the differences between generics and biosimilars, describe their respective regulatory approval pathways, discuss interchangeability and substitution, and review substitution of interchangeable biosimilars, focusing on key professional considerations for pharmacists.

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Section: ■■ Considerations For Interchangeable Biosimilar Substitutionmentioning

confidence: 99%

Pharmacist Substitution of Biological Products: Issues and Considerations

Ramanan²,

Green³

2015

JMCP

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“…Regulatory agencies in the USA and Europe have also noted the importance of tracing adverse events back to the original manufacturer and biologic product for drugs that are allowed to be substituted, for drugs that are not considered interchangeable and for drugs that are considered interchangeable [6,11,12]. At this time, policy makers are reviewing biosimilar nomenclature to ensure patient access and safety [13,14].…”

Section: Biosimilars and Global Interchangeabilitymentioning

confidence: 99%

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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“…The arithmetic of the proposed scheme with regard to the dates over which revenue would be escrowed for small-molecule drugs is straightforward; the patent expiration dates (nominally 20 years from filing; see Further information) and profits (filed with the SEC) are known. However, although the same is true in principle for biologics, the situation is complicated by the lack of certainty over the market entry pathway for biosimilars in the United States 6,7 ; at present, it could be anticipated that branded biologics may continue to have no biosimilar competitors for some time after the expiry of the relevant patents. Moreover, in Europe (where mechanisms for biosimilar approval have been established for several years), biosimilars have only won 25-30% of the market share, compared with up to 80% for generic versions of smallmolecule drugs 8 .…”

Section: Characteristics Of the Planmentioning

confidence: 99%