Pharmacovigilance and biosimilars: considerations, needs and challenges

Casadevall, Nicole; Edwards, I Ralph; Felix, Thomas; Graze, Peter R.; Litten, Jason B.; Strober, Bruce; Warnock, David G.

doi:10.1517/14712598.2013.783560

Cited by 72 publications

(61 citation statements)

References 23 publications

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“…29 In addition, more proactive measures to evaluate long-term safety (such as participation in registries with ongoing evaluation of safety in the clinical setting) are often employed. These longterm, proactive plans are designed to understand the nature and frequency of adverse events and possible identification of risk factors.…”

Section: Post-approval Considerationsmentioning

confidence: 99%

Clinical considerations for the development of biosimilars in oncology

Socinski

Curigliano

Jacobs

et al. 2015

mAbs

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Section: Post-approval Considerationsmentioning

confidence: 99%

Clinical considerations for the development of biosimilars in oncology

Socinski

Curigliano

Jacobs

et al. 2015

mAbs

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“…41 Post-approval pharmacovigilance monitoring will include patient registries for assessment of safety issues, voluntary, spontaneous reporting of adverse events (AEs) and medication errors to the manufacturer or FDA by healthcare professionals and patients, as well as mandatory AE reporting by manufacturers to the FDA. 41 Cost-effective pharmacovigilance programs are evolving, including the Sentinel Initiative holding promise.…”

Section: Fda = Food and Drug Administration; Pd = Pharmacodynamic; Pkmentioning

confidence: 99%

Biosimilars in Oncology

Zelenetz¹

2016

Oncology &Amp; Hematology Review (US)

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The escalating cost of cancer care is placing an increasing burden on healthcare systems worldwide, largely a result of expensive biologic therapies. With the patents on many biologics expiring, interest in biosimilars is rising. Biosimilars of biologic agents used for cancer treatment and supportive care are making their appearance in the US; this article therefore aims to increase understanding of the biosimilars concept. Biosimilars are very comparable to their reference products, but because of their size and complexity, are not identical. However, the inherent structural differences between biologics and their reference products may not translate to clinically meaningful differences in efficacy and safety. Biosimilars offer potential cost savings but present a challenge in terms of establishing a regulatory pathway. Regulatory approval requires comparative analytical and clinical studies in order to characterize and demonstrate the absence of clinically meaningful differences between biosimilars and their reference products. Initial approval may not include interchangeability, as additional evidence may be required before a biosimilar can be designated interchangeable with its reference product. A framework for the approval of biosimilars was established by the European Medicines Agency (EMA) in 2006 with the first biosimilar approved in April, 2006. Thus, the experience in Europe provides valuable insights into the use of biosimilars. The widespread use of biosimilars has the potential to reduce healthcare expenditure, as well as improving patient access without compromising patient outcomes, but clinician education and acceptance is crucial.

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“…Each biosimilar product should be readily distinguishable from the reference product and other biosimilars to ensure appropriate use, traceability, and accurate reporting of ADRs. 43 Different countries, such as Japan, have adopted their own policies for biosimilar naming. Currently in Japan, the non-proprietary and proprietary names of biosimilars should be easily distinguishable from those of other biosimilars and those of the reference products, according to the guidance released by the Pharmaceuticals and Medical Devices Agency, the Japanese regulatory agency.…”

Section: International Nonproprietary Names and Naming Of Biosimilarsmentioning

confidence: 99%