Anti-tumor necrosis factor patent expiration and the risks of biocopies in clinical practice

Scheinberg, Morton; Castañeda‐Hernández, Gilberto

doi:10.1186/s13075-014-0501-5

Cited by 22 publications

(22 citation statements)

References 15 publications

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“…Biomimics may differ from originator biologics in their primary structure, dosage, and formulation, which may result in clinically significant differences in efficacy or safety, with the potential to compromise patient care [38]. In Mexico, where biomimics are marketed, there has been automatic substitution by pharmacies of etanercept and rituximab biomimics for the originator products [39]. The lack of adequate post-marketing surveillance programs in some countries, where biomimics are substituted for originator biopharmaceuticasls in an unregulated manner, puts patients at risk for adverse outcomes.…”

Section: A Naming Convention Should Be Implemented To Clearlymentioning

confidence: 99%

PANLAR consensus statement on biosimilars

Kowalski

Benavides²,

Roa³

et al. 2019

Clin Rheumatol

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Introduction Biologics have improved the treatment of rheumatic diseases, resulting in better outcomes. However, their high cost limits access for many patients in both North America and Latin America. Following patent expiration for biologicals, the availability of biosimilars, which typically are less expensive due to lower development costs, provides additional treatment options for patients with rheumatic diseases. The availability of biosimilars in North American and Latin American countries is evolving, with differing regulations and clinical indications. Objective The objective of the study was to present the consensus statement on biosimilars in rheumatology developed by Pan American League of Associations for Rheumatology (PANLAR). Methods Using a modified Delphi process approach, the following topics were addressed: regulation, efficacy and safety, extrapolation of indications, interchangeability, automatic substitution, pharmacovigilance, risk management, naming, traceability, registries, economic aspects, and biomimics. Consensus was achieved when there was agreement among 80% or more of the panel members. Three Delphi rounds were conducted to reach consensus. Questionnaires were sent electronically to panel members and comments about each question were solicited. Results Eight recommendations were formulated regarding regulation, pharmacovigilance, risk management, naming, traceability, registries, economic aspects, and biomimics. Conclusion The recommendations highlighted that, after receiving regulatory approval, pharmacovigilance is a fundamental strategy to ensure safety of all medications. Registries should be employed to monitor use of biosimilars and to identify potential adverse effects. The price of biosimilars should be significantly lower than that of reference products to enhance patient access. Biomimics are not biosimilars and, if they are to be marketed, they must first be evaluated and approved according to established regulatory pathways for novel biopharmaceuticals. Key Points • Biologics have improved the treatment of rheumatic diseases. • Their high cost limits access for many patients in both North America and Latin America. • Biosimilars typically are less expensive, providing additional treatment options for patients with rheumatic diseases. • PANLAR presents its consensus on biosimilars in rheumatology

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Section: A Naming Convention Should Be Implemented To Clearlymentioning

confidence: 99%

PANLAR consensus statement on biosimilars

Kowalski

Benavides²,

Roa³

et al. 2019

Clin Rheumatol

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“…With the recent expiration of patents around the world protecting numerous high‐cost, branded biologic drugs, biosimilars have been developed and introduced in several countries, offering competition and reduced prices . In South Korea, we found that utilization of a newly introduced biosimilar infliximab agent comprised one‐fifth of all infliximab prescription claims within 15 months after its introduction.…”

Section: Discussionmentioning

confidence: 92%

Brief Report: Utilization of the First Biosimilar Infliximab Since Its Approval in South Korea

Kim

Choi

Lee

et al. 2016

Arthritis & Rheumatology

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Objective The US Food and Drug Administration is considering an application for a biosimilar version of infliximab, which has been available in South Korea since November 2012. The aim of the present study was to examine the utilization patterns of both branded and biosimilar infliximab and other tumor necrosis factor (TNF) inhibitors in South Korea before and after the introduction of this biosimilar infliximab. Methods Using claims data from April 2009 to March 2014 from the Korean Health Insurance Review and Assessment Service database, which includes the entire South Korean population, the number of claims for biosimilar infliximab was assessed. A segmented linear regression model was used to examine the utilization patterns of infliximab (the branded and biosimilar versions) and other TNF inhibitors (adalimumab and etanercept) before and after the introduction of the biosimilar infliximab. Results In total, 20,976 TNF inhibitor users were identified from the South Korean claims database, including 983 with a prescription claim for biosimilar infliximab. Among all of the claims for any version of infliximab, the proportion of biosimilar infliximab claims increased to 19% through March 2014. Before November 2012, each month there were 33 (95% confidence interval [95% CI] 32, 35) more infliximab claims, 44 (95% CI 40, 48) more etanercept claims, and 50 (95% CI 47, 53) more adalimumab claims. After November 2012, there were significant changes in the slopes for trend in usage, with additional increases in the use of branded and biosimilar infliximab (9 more claims per month, 95% CI 2, 17) and decreases in the use of etanercept (−52 claims per month, 95% CI −66, −38) and adalimumab (−21 claims per month, 95% CI −35, −6). Conclusion During the first 15 months since its introduction in South Korea, one‐fifth of all infliximab claims were for the biosimilar version. Introduction of biosimilar infliximab may affect the use of other TNF inhibitors, and the magnitude of change in usage will likely differ in other countries.

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“…2,16,44,57 A 2016 systematic literature review found that most comparative studies reported for such intended copies were either analytical, non-clinical, or observational in nature; as such, there remains a significant dearth of published data demonstrating the safety and efficacy of these agents. 16 …”

Section: Biosimilars In Latin America: Current Situationmentioning

confidence: 99%

“…45 Indeed, suboptimal surveillance processes and systems reportedly contributed to delays in the withdrawal of Kikuzubam®. 2 …”

Section: Biosimilars In Latin America: Current Situationmentioning

confidence: 99%

“…144 The product provided to the patient may be unknown to the recipient and the prescriber in many cases, 154 and substitution is a particular concern in countries where intended copies are in use. 2,84 Information on pharmacy-mediated substitution of biosimilars was collected for 13 Latin American countries in a 2017 global survey; Peru was the only country in the region for which it was indicated that substitution could occur. 155 Although substitution was reported not to occur in the other 12 countries, in all but one case, this appeared to be based on respondents’ knowledge of normal pharmacy practices, rather than any regulation or guidance to prevent it.…”

Section: Implications and Considerations For Clinicians In Latin Americamentioning

confidence: 99%

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Biosimilars in oncology and inflammatory diseases: current and future considerations for clinicians in Latin America

Scheinberg

Pineda

Castañeda‐Hernández

et al. 2018

mAbs

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Biological therapies have revolutionized the treatment of several cancers and systemic immune-mediated inflammatory conditions. Expiry of patents protecting a number of biologics has provided the opportunity to commercialize highly similar versions, known as biosimilars. Biosimilars are approved by regulatory agencies via an independent pathway that requires extensive head-to-head comparison with the originator product. Biosimilars have the potential to provide savings to healthcare systems and expand patient access to biologics. In Latin American countries, regulatory frameworks for biosimilar approval have been introduced in recent years, and biosimilars of monoclonal antibody and fusion protein therapies are now emerging. However, the situation in this region is complicated by the presence of “non-comparable biotherapeutics” (also known as “intended copies”), which have not been rigorously compared with the originator product. We review the considerations for clinicians in Latin American countries, focusing on monoclonal antibody biosimilars relevant to oncology, rheumatology, gastroenterology, and dermatology.

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Anti-tumor necrosis factor patent expiration and the risks of biocopies in clinical practice

Cited by 22 publications

References 15 publications

PANLAR consensus statement on biosimilars

PANLAR consensus statement on biosimilars

Brief Report: Utilization of the First Biosimilar Infliximab Since Its Approval in South Korea

Biosimilars in oncology and inflammatory diseases: current and future considerations for clinicians in Latin America

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