Biosimilar Products in the Modern U.S. Health Care and Regulatory Landscape

Peterson, Julia; Budlong, Holly; Affeldt, Tim; Skiermont, Kyle; Kyllo, Gregg; Heaton, Al

doi:10.18553/jmcp.2017.23.12.1255

Cited by 8 publications

(8 citation statements)

References 3 publications

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“…2 This less expensive, abbreviated pathway was designed to introduce competition among biologic manufacturers, control costs, and reduce health care spending on these agents. 3 Indications from the reference product may be extrapolated to the biosimilar(s), but the FDA may require clinical trials to be conducted in some indications to assess additional safety and efficacy outcomes. 3,4 Unlike generic drugs, biosimilars are not identical to the approved reference product.…”

Section: Overviewmentioning

confidence: 99%

“…3 Indications from the reference product may be extrapolated to the biosimilar(s), but the FDA may require clinical trials to be conducted in some indications to assess additional safety and efficacy outcomes. 3,4 Unlike generic drugs, biosimilars are not identical to the approved reference product. Therefore, substitution of the reference product with a biosimilar is not permitted without prescriber intervention, unless granted interchangeability status from the FDA.…”

Section: Overviewmentioning

confidence: 99%

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The formulary process for biosimilar additions at a comprehensive cancer center

Aschermann

Forshay

Kennerly-Shah

et al. 2021

J Oncol Pharm Pract

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Biological products may be used to diagnose, prevent, treat, and cure diseases and medical conditions, including cancer. Biosimilar agents, approved under an abbreviated 351(k) pathway, continue to increase in number and market share for biologic agents, especially for cancer care. Although biosimilars offer the potential for improved access to care, their introduction to the marketplace has created significant disruption. It is imperative that health systems providing care to patients with cancer develop a well-defined process to address the challenges associated with biosimilars. This descriptive article outlines pharmacy considerations for biosimilars and describes the current practices at The Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at The Ohio State University. Biosimilars have and will continue to significantly impact oncology care. Organizations must understand the clinical, operational, and financial challenges associated with the use of these products.

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Section: Overviewmentioning

confidence: 99%

Section: Overviewmentioning

confidence: 99%

The formulary process for biosimilar additions at a comprehensive cancer center

Aschermann

Forshay

Kennerly-Shah

et al. 2021

J Oncol Pharm Pract

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“…The pharmaceutical company has to develop complex biosimilars that mimic the original "innovator" drugs and explore analytical methods to demonstrate similarity to regulatory authorities [25]. A comment outlines the efforts of an integrated health system to ensure biosimilar accessibility and discusses the current challenges and future implications [27]. Biosimilars still confront regulatory challenges on potential implications for pricing, site of care, and pharmacy dispensing practices [27].…”

Section: Biosimilarmentioning

confidence: 99%

“…A comment outlines the efforts of an integrated health system to ensure biosimilar accessibility and discusses the current challenges and future implications [27]. Biosimilars still confront regulatory challenges on potential implications for pricing, site of care, and pharmacy dispensing practices [27]. Generally, we believe that biosimilars are helpful to the health-care system, but their expected benefits may not be understood in the near future.…”

Section: Biosimilarmentioning

confidence: 99%

Introductory Chapter: Biopharmaceuticals

Chen¹,

Yeh²

2018

Biopharmaceuticals

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“…Following the first approval of Fc-fusion protein, Enbrel in 1998, eight Fc-fusion proteins are authorized for the marketing in the region of Europe and USA.Biosimilars, known as follow-on biologics, which follow termination of patent protection of original biopharmaceutical products, are developed and approved since 2006. Following the first approval from EMA, over 35 biosimilars are authorized for the European market and over 20 biosimilars are approved from FDA since 2015 [16][17][18]. A biosimilar is a biological product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product in terms of safety, purity, and potency (safety and effectiveness) [19].…”

mentioning

confidence: 99%

Characterization of Biopharmaceuticals Focusing on Antibody Therapeutics

Kim¹,

Kang²,

Suh³

2018

Biopharmaceuticals

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Biopharmaceuticals are highly complex molecules and also require high quality for safety and efficacy in human uses. For well-characterized products, the desired level of quality should be monitored and controlled during the manufacturing processes. A series of workflow for analytical characterization should be applied for product quality throughout those processes. In this chapter, several analytical techniques are introduced for assessing characteristics of biopharmaceuticals focusing on monoclonal antibodies (mAbs). Analytical characterization for primary structure was performed by mass spectrometry (MS), and assessment of post-translational modifications (PTMs) was done by conventional approaches. The analytical assessments were also done by multi-attribute method (MAM) approach using mass spectrometer (MS), and the performance of MAM was compared to conventional approaches. on the market results in gaining interest for drug development industry, and biopharmaceuticals are considered as fast growing and promising area for drug development [3][4][5][6].The approval of mAb-related products is dramatically increased in the recent years [6,7]. Over 90 mAb-related products are approved by European Medicines Agency (EMA) and US Food and Drug Administration (FDA). Those can be classified into mAb, Fc-fusion, Fab, antibody-drug conjugate (ADC), bispecific mAb (bsAb), and bispecific T cell engager (BiTE). Among them, mAbs are the major product, consisting of 77% of total. Others represent rest 23% of total, Fc-fusion (12%), ADC (5%), Fab (3%), bsAb (2%), and BiTE (1%), respectively. After the first approval of full-length mAb in 1998, mAbs are major product in the biopharmaceutical industry. This increasing number gives high revenue for pharmaceutical companies, and seven mAb-related products are positioned in top 10 drugs in the world, 2017, including Humira, Enbrel, Rituxan, Remicade, AVASTIN, Herceptin, and Lantus [8].Mylotarg is the first approved ADC in 2000, which combined a mAb targeting leukemic blast cells with a bacterial toxin (calicheamicin) [7,9]. ADC is a complex generated between a mAb and small molecule or a peptide, and mAb gives the selective delivery for targeting of cytotoxic drugs [1,[9][10][11]. Since the first approval, four additional ADC products are approved in Europe and USA. bsAb has two different antigen binding sites recognizing two different epitopes in a single mAb, and this dual specificity gives more specific targeting and higher efficacy [12][13][14]. Currently, three bsAbs are approved by EMA or US FDA. The first bsAb, Removab, was approved in 2009 but voluntarily withdrawn in 2013. Fc-fusion proteins are fusions of the IgG Fc domain with a desired linked protein, enhancing pharmacokinetic properties (serum half-life) and pharmacodynamics properties (ADCC and CDC) [6,15]. Following the first approval of Fc-fusion protein, Enbrel in 1998, eight Fc-fusion proteins are authorized for the marketing in the region of Europe and USA.Biosimilars, known as follow-on biologics, which follow t...

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Biosimilar Products in the Modern U.S. Health Care and Regulatory Landscape

Cited by 8 publications

References 3 publications

The formulary process for biosimilar additions at a comprehensive cancer center

The formulary process for biosimilar additions at a comprehensive cancer center

Introductory Chapter: Biopharmaceuticals

Characterization of Biopharmaceuticals Focusing on Antibody Therapeutics

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