Biosimilars Are Here: A Hospital Pharmacist's Guide to Educating Health Care Professionals on Biosimilars

Jarrett, Steven; Dingermann, Theodor

doi:10.1310/hpj5010-884

Cited by 25 publications

(24 citation statements)

References 23 publications

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“…Many biological medicines (reference medicines) have a competitive version, produced by other manufacturers from other cell lines, known as biosimilar medicines (biosimilars). They are not identical, but have functional and structural similarities, which should be reflected in their safety, efficacy and clinical properties [ 1 – 3 ]. Biosimilars are new medicines that were first approved by the European Medicines Agency (EMA) in 2006 [ 4 ].…”

Section: Introductionmentioning

confidence: 99%

Perspectives of Hospital Pharmacists Towards Biosimilar Medicines: A Survey of Polish Pharmacy Practice in General Hospitals

et al. 2019

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Introduction There has been a significant increase in the volume of biosimilar medicines recently due to the expiries of patent protections of biologic medicines. Biosimilars are considered new medicines, and their usage in therapy is often associated with uncertainty from the perspectives of physicians, pharmacists and patients. Objectives The purpose of this study was to identify hospital pharmacist opinions towards these new medicines and investigate their usage in practice. Methods A paper-based, self-administered questionnaire was distributed to Polish hospital pharmacists. Results Biosimilars were used in 77% of surveyed hospitals, whereas originator biologics were utilised within 90% of settings. The former medicines were found to consist of less than one-third of the entire course of biological pharmacotherapy used within Polish hospitals. A total of 88% of hospital pharmacists were concerned that the new drugs were not identical with the biologic versions, 48% with their immunogenicity and 44% with other pharmacokinetic properties. The majority of respondents (87%) stated that the most important advantage of biosimilars related to decreased costs. Furthermore, according to participants, pharmacist-led substitution is not appropriate. Conclusion Due to the numerous concerns relating to the usage of biosimilars, their introduction into patient therapy requires special attention from healthcare providers. While pharmacists involved in the distribution of biosimilars are conscious of their impact in decreasing costs of therapy, they do not feel comfortable in recommending their substitution without a physician's permission. There is a need for more precise legal regulations relating to biosimilars, improved communication between physicians and pharmacists, as well as educational initiatives to improve the safe and effective usage of biosimilars.

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Section: Introductionmentioning

confidence: 99%

Perspectives of Hospital Pharmacists Towards Biosimilar Medicines: A Survey of Polish Pharmacy Practice in General Hospitals

et al. 2019

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“…It is expected that some physicians and patients will display a level of resistance to accept new drugs due to uncertainty and inadequate information. It is the responsibility of the pharmacist both at the community level and in the health care institute to inform all stakeholders involved in the use of biosimilars [29]. Educating the patients and counseling is one of the main responsibilities of the pharmacist.…”

Section: The Roles Of the Pharmacist In Education And Counselingmentioning

confidence: 99%

“…Biosimilars will be able to attain a good market share and potential price reduction only when pharmacists are able to educate and convince the physician and patients to accept biosimilars [29][30].…”

Section: The Roles Of the Pharmacist In Education And Counselingmentioning

confidence: 99%

“…Post-marketing monitoring of biosimilar products or pharmacovigilance is a requirement in all biosimilar guidelines due to limited clinical trials. Pharmacists are at a pivotal position to enable collection of pharmacovigilance data and post-marketing monitoring in many countries [27][28][29][30]. Adequate involvement of pharmacists is important to ensure that all identification information about the dispensed biosimilar such as the name of the product, batch number, manufacturing company, indication, etc.…”

Section: The Roles Of the Pharmacist In Pharmacovigilance And Post-mamentioning

confidence: 99%

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The role of the pharmacist from development to pharmacovigilance of biosimilars

Kunter¹,

Balogun²,

Şahin³

2018

jrp

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Biologics such as vaccines, recombinant proteins and antibodies are used to treat or prevent different chronic and complex diseases and they have a high market share. Improvements in biotechnology, leads increased production and use of these products. Because of high manufacturing cost, they are expensive and have significant drawbacks about their use and patient accessibility. Biosimilars are cost-effective therapeutic alternatives of biologics, which can be marketed after the expiry of the patent of the reference biologic. Biosimilars can provide cheaper alternatives and they can help reduce health care expenditure significantly. Although there are many publications related to the importance of biosimilars in the literature, there are not enough studies on the role of the pharmacist from development to pharmacovigilance of these drugs. In this article, besides the importance of these drugs we addressed the crucial contribution of the pharmacists in preparation of biosimilar drugs, establishing regulations and approval pathways to take place in the market and the investigation of the side effects after marketing. We also emphasized the role of pharmacist at development, manufacturing, dispensing, post-marketing pharmacovigilance, regulations and usage of biosimilars.

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“…Filgrastim-sndz (Zarxio; Sandoz/Novartis) was the first biosimilar (to filgrastim [Neupogen]) approved in the US in March 2015 [42]. It was approved in Europe in 2009.…”

Section: Filgrastimmentioning

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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Biosimilars Are Here: A Hospital Pharmacist's Guide to Educating Health Care Professionals on Biosimilars

Abstract: It is important to educate health care providers about the differences between biosimilars and their reference biologics. The adoption of biosimilars is necessary to control long-term costs of biologics, increase patient access to care, and encourage innovation.

Cited by 25 publications

References 23 publications

Perspectives of Hospital Pharmacists Towards Biosimilar Medicines: A Survey of Polish Pharmacy Practice in General Hospitals

Perspectives of Hospital Pharmacists Towards Biosimilar Medicines: A Survey of Polish Pharmacy Practice in General Hospitals

The role of the pharmacist from development to pharmacovigilance of biosimilars

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

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