Can biosimilars help achieve the goals of US health care reform?

Boccia, Ralph V.; Jacobs, Ira; Popovian, Robert; Lopes, Gilberto

doi:10.2147/cmar.s133442

Cited by 16 publications

(18 citation statements)

References 22 publications

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“…A lot of opportunities are present for emerging biosimilar markets where the majority of biologics that are prevalent in the market are non-originators [127]. Defined by IMS Health as “pharmemerging markets”, they consist of several markets (China, Algeria, Brazil, Argentina, India, Egypt, Colombia, Indonesia, Mexico, Turkey, Saudi Arabia, Pakistan Thailand, and Venezuela) [128].…”

Section: Marketing Perspective Of Biosimilarsmentioning

confidence: 99%

The Breakthrough of Biosimilars: A Twist in the Narrative of Biological Therapy

2019

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The coming wave of patent expiries of first generation commercialized biotherapeutical drugs has seen the global market open its doors to close copies of these products. These near perfect substitutes, which are termed as “biosimilars”, do not need to undergo intense clinical trials for their approval. However, they are mandated to produce identical similarity from their reference biologics in terms of clinical safety and efficacy. As such, these biosimilar products promise to foster unprecedented access to a wide range of life-saving biologics. However, seeing this promise be fulfilled requires the development of biosimilars to be augmented with product trust, predictable regulatory frameworks, and sustainable policies. It is vital for healthcare and marketing professionals to understand the critical challenges surrounding biosimilar use and implement informed clinical and commercial decisions. A proper framework of pharmacovigilance, education, and scientific exchange for biologics and biosimilars would ensure a dramatic rise in healthcare access and market sustainability. This paper seeks to collate and review all relevant published intelligence of the health and business potential of biosimilars. In doing so, it provides a visualization of the essential steps that are required to be taken for global biosimilar acceptance.

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Section: Marketing Perspective Of Biosimilarsmentioning

confidence: 99%

The Breakthrough of Biosimilars: A Twist in the Narrative of Biological Therapy

2019

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“…Barriers affecting biosimilar uptake have been previously documented and discussed in the literature. 4,[8][9][10][11][12][13] These studies highlight that biosimilar adoption is heavily influenced by stakeholders, including providers, patients, and payers. 14,15 From a payer perspective, decision making is often influenced by the cost difference between a biosimilar and its reference product or rebates that they may receive from the manufacturers for formulary preference.…”

Section: ■■ Discussionmentioning

confidence: 99%

Process and Clinical Outcomes of a Biosimilar Adoption Program with Infliximab-Dyyb

Bhat

Altajar

Shankar

et al. 2020

JMCP

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BACKGROUND: In 2016, the FDA approved infliximab-dyyb (IFX-dyyb) as a biosimilar to infliximab (IFX). Deemed to have comparable efficacy and safety to IFX, IFX-dyyb is 20%-30% less expensive, allowing significant cost savings for institutions and some payers. In 2018, IFX was reported to be the drug with the highest spend since 2013, costing $3.8 billion; however, transition to IFX-dyyb would save $1.1 billion. Regardless, many institutions have not transitioned to IFX-dyyb or other IFX biosimilars (e.g., IFXabda) because of concerns about clinical outcomes, uncertainty regarding financial impact, and barriers to operationalizing biosimilar adoption. At Boston Medical Center, a decision was made in March 2018 to adopt IFXdyyb and transition patients who have been on IFX for ≥ 6 months for all indications to IFX-dyyb.OBJECTIVES: To (a) describe a biosimilar adoption process of IFX-dyyb in patients on IFX for ≥ 6 months; (b) characterize cost savings of transitioning patients to IFX-dyyb; and (c) evaluate real-world clinical outcomes of adult patients with inflammatory bowel disease (IBD) who transitioned to IFX-dyyb. METHODS: This is a retrospective cohort study of patients eligible for the IFX-dyyb switch from March 2018 to June 2019 at a large academic medical center. For process outcomes, we collected the proportion of patients who transitioned to IFX-dyyb and calculated the cost savings generated. To assess clinical outcomes of adult IBD patients who transitioned, we collected IFX and IFX-dyyb dosage, Harvey Bradshaw Index (HBI) or Simple Clinical Colitis Activity Index (SCCAI) scores, c-reactive protein (CRP) levels, and colonoscopy results. Descriptive statistics, Wilcoxon signed-rank test, and McNemar's test were used for statistical analyses. RESULTS: Of 151 eligible patients, 146 (97%) successfully transitioned to IFX-dyyb. Based on our conversion rate to IFX-dyyb, our health system is forecasted to save approximately $500,000 annually. From March to June 2018, 63 of 75 (84%) eligible IBD patients transitioned from IFX to IFXdyyb. In this cohort, of the 40 patients with HBI or SCCAI scores before and after transition, 36 (90%) maintained remission. For 32 patients, the mean CRP (SD) before transition was 11.2 (22) and 4.1 (4.8) after transition (P = 0.09). Since the IFX-dyyb transition, 9 patients had a colonoscopy, of which 5 (56%) were in endoscopic remission. As of October 2018, 56 (89%) patients continued with IFX-dyyb after transition. Of the 46 patients who had 12-15 months posttransition data, 38 (83%) remained on IFX-dyyb.CONCLUSIONS: Implementation of a biosimilar adoption program can be successful and result in significant cost savings without compromising clinical outcomes. A model that uses actionable strategies and embraces collaboration among stakeholders is described here, with outcomes demonstrating successful IFX-dyyb uptake and no changes in clinical outcomes of transitioned adult patients with IBD.

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“…Opportunities exist for biosimilars in the emerging economies ( Boccia et al, 2017 ), due to low treatment rates with biologics and constraints of affordability. However, a strong and clear regulatory framework is required to unlock the potential of biosimilars in these markets.…”

Section: Introductionmentioning

confidence: 99%

Comparison of BRICS-TM Countries' Biosimilar Regulatory Frameworks With Australia, Canada and Switzerland: Benchmarking Best Practices

Rahalkar

Sheppard²,

Salek

2021

Front. Pharmacol.

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Objectives: The aim of this study was to identify, compare and evaluate regulatory requirements for the biosimilar development and review processes in BRICS-TM (Brazil, Russia, India, China, South Africa, Turkey, Mexico) countries with mature regulatory systems of Australia, Canada, Singapore and Switzerland. It is hoped that this benchmark study provides an opportunity for BRICS-TM agencies to identify the key areas for improvement in their regulatory processes.Materials and Methods: A semi-quantitative questionnaire was developed covering the different criteria used in biosimilar development and registration process. Eleven regulatory agencies from BRICS-TM and ACSS (Australia, Canada, Switzerland and Singapore) countries were invited to take part in this study. Data processing and analysis was carried out using descriptive statistics for quantitative data and content analysis to generate themes for qualitative data.Results and Discussions: Nine of the 11 regulatory agencies recruited for the study completed the questionnaire. China and Singapore did not meet the deadline due to lack of resources. The organisational structure of BRICS-TM agencies revealed support from external assessors by most of these agencies in comparison with ACSS agencies. There was absence of reliance approach and participation in harmonisation activities across most BRICS-TM agencies. Despite alignment over biosimilarity, the mandate for in vivo non-clinical studies and additional local clinical studies in some of the BRICS-TM countries illustrates a lack of effective implementation of a step-wise approach. Adopting flexible regulatory standards in the sourcing of a RBP (Reference Biologic Product) by BRICS-TM similar to ACSS, will facilitate cost-effective development of biosimilar products.Conclusions: Comparative assessment of the biosimilar regulatory framework of BRICS-TM with ACSS agencies reveals the scope for enhancing efficiency of the regulatory approval process. To achieve this, BRICS-TM agencies should consider relying on reference agencies for alternative review mechanisms such as abridged or verification models, streamlined processes for providing scientific advice to developers and for waiving local clinical studies in-lieu of advanced scientific data.

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Can biosimilars help achieve the goals of US health care reform?

Cited by 16 publications

References 22 publications

The Breakthrough of Biosimilars: A Twist in the Narrative of Biological Therapy

The Breakthrough of Biosimilars: A Twist in the Narrative of Biological Therapy

Process and Clinical Outcomes of a Biosimilar Adoption Program with Infliximab-Dyyb

Comparison of BRICS-TM Countries' Biosimilar Regulatory Frameworks With Australia, Canada and Switzerland: Benchmarking Best Practices

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