Biosimilars in Developed Economies: Overview, Status, and Regulatory Considerations

Rathore, Anurag S.; Bhargava, Ankita

doi:10.1016/j.yrtph.2019.104525

Cited by 14 publications

(7 citation statements)

References 15 publications

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“…Following the patent cliff of certain innovator products and the growing support from the major regulatory agencies, there has been a steady increase in the number of biosimilar approvals. At present, region and country-specific biosimilar regulatory pathways and guidance are at different stages of development and implementation ( Rathore and Bhargava, 2020 ; 2021a ; 2021b ; 2021c ). There is a growing interest in increasing global harmonization of the regulatory guidelines for biosimilar development including selection of the reference product, nomenclature, and the design of analytical, non-clinical, or clinical biosimilarity studies.…”

Section: Global Landscape On Biosimilar Approvalsmentioning

confidence: 99%

Analytical Similarity Assessment of Biosimilars: Global Regulatory Landscape, Recent Studies and Major Advancements in Orthogonal Platforms

Nupur

Joshi

Gulliarme

et al. 2022

Front. Bioeng. Biotechnol.

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Biopharmaceuticals are one of the fastest-growing sectors in the biotechnology industry. Within the umbrella of biopharmaceuticals, the biosimilar segment is expanding with currently over 200 approved biosimilars, globally. The key step towards achieving a successful biosimilar approval is to establish analytical and clinical biosimilarity with the innovator. The objective of an analytical biosimilarity study is to demonstrate a highly similar profile with respect to variations in critical quality attributes (CQAs) of the biosimilar product, and these variations must lie within the range set by the innovator. This comprises a detailed comparative structural and functional characterization using appropriate, validated analytical methods to fingerprint the molecule and helps reduce the economic burden towards regulatory requirement of extensive preclinical/clinical similarity data, thus making biotechnological drugs more affordable. In the last decade, biosimilar manufacturing and associated regulations have become more established, leading to numerous approvals. Biosimilarity assessment exercises conducted towards approval are also published more frequently in the public domain. Consequently, some technical advancements in analytical sciences have also percolated to applications in analytical biosimilarity assessment. Keeping this in mind, this review aims at providing a holistic view of progresses in biosimilar analysis and approval. In this review, we have summarized the major developments in the global regulatory landscape with respect to biosimilar approvals and also catalogued biosimilarity assessment studies for recombinant DNA products available in the public domain. We have also covered recent advancements in analytical methods, orthogonal techniques, and platforms for biosimilar characterization, since 2015. The review specifically aims to serve as a comprehensive catalog for published biosimilarity assessment studies with details on analytical platform used and critical quality attributes (CQAs) covered for multiple biotherapeutic products. Through this compilation, the emergent evolution of techniques with respect to each CQA has also been charted and discussed. Lastly, the information resource of published biosimilarity assessment studies, created during literature search is anticipated to serve as a helpful reference for biopharmaceutical scientists and biosimilar developers.

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Section: Global Landscape On Biosimilar Approvalsmentioning

confidence: 99%

Analytical Similarity Assessment of Biosimilars: Global Regulatory Landscape, Recent Studies and Major Advancements in Orthogonal Platforms

Nupur

Joshi

Gulliarme

et al. 2022

Front. Bioeng. Biotechnol.

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“…Moreover, the use of biosimilar infliximab in DPC hospitals could be one key factor that determines the introduction timeline and penetration of each biosimilar in Japan. 8 Therefore, our results may be helpful in understanding the current situation of biosimilars in Japan.…”

Section: Limitations Of the Studymentioning

confidence: 86%

“…5 A number of biosimilars have been approved as highly similar to their reference products, following studies required to show that they have no clinically significant differences in safety, purity, or potency (safety and effectiveness) compared with the reference product. 6,7 Considering that only biosimilar products that meet rigorous standards are approved by regulatory authorities, 8 physicians and patients should have no concern regarding their use. However, the truth of the matter is that some physicians lack the confidence to prescribe biosimilars, while patients receive insufficient explanations regarding biosimilars from physicians.…”

Section: Introductionmentioning

confidence: 99%

Changes in the Penetration Rate of Biosimilar Infliximab Within Japan Using a Japanese Claims Database

Matsumoto¹,

Tsuchiya

Hirano³

et al. 2021

CEOR

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Purpose Infliximab, which was approved in 2002, had its first biosimilar launched in 2014 across Japan. However, the penetration rate of this biosimilar remains unclear given the limited data regarding its current clinical use throughout Japan. This study was conducted to describe the current clinical characteristics of patients receiving infliximab and the penetration rate of the reference infliximab and/or biosimilar infliximab using a Japanese administrative claims database. Patients and Methods This retrospective, descriptive study utilized the Japan Medical Data Vision database, a nationwide hospital-based database. Data on patients receiving infliximab recorded from April 2008 to March 2019 were extracted from the database. Patient characteristics of the reference and biosimilar infliximab groups and penetration rates according to fiscal year, target diseases diagnosis, and subsidy for intractable diseases were examined. Results A total of 9735 patients were extracted for analysis, among whom 92% (n=8950) and 8% (n=785) received only reference infliximab and its biosimilar, respectively. Both groups exhibited similar clinical characteristics. The biosimilar penetration rate increased from 0.8% in 2014 to 22.5% in 2018, with overall penetration rates throughout the period according to diagnosis (with or without subsidy) being 14.4% (with, 4.1%; without, 16.4%), 4.7% (with, 3.7%; without, 10.6%), 5.7% (with, 4.5%; without, 13.5%), and 7.5% (with, 4.4%; without, 8.2%) for rheumatoid arthritis, Crohn’s disease, ulcerative colitis, and psoriasis, respectively. Conclusion Biosimilar infliximab is prescribed for patients with similar characteristics to reference infliximab. Despite the increasing penetration rates according to target disease, they remain much lower among patients receiving subsidy for intractable disease than among those who do not.

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“…We chose these three main biologics because they are the most prescribed rst-line biologics DMARDs in RA (24). Also, these three DMARDS have the highest numbers of approved biosimilars for RA in the market (13,25).…”

Section: Types Of Biosimilarsmentioning

confidence: 99%

Equivalence and switching between biosimilars and reference molecules in rheumatoid arthritis: protocol for two systematic reviews and meta-analyses

Ascef

Almeida

Ribeiro

et al. 2020

Preprint

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Background Biologic drugs such as adalimumab, etanercept, and infliximab represent major first-line and second-line treatments for rheumatoid arthritis (RA) patients. However, their high cost poses a massive burden on healthcare systems worldwide. The expiration of patents for these biologics has driven to the production of biosimilar drugs, which are potentially less costly and remarkably similar, albeit not identical to the reference molecules. These two systematic reviews aim to investigate the efficacy and safety profile of biosimilars compared to biologics (systematic review 1) and the impact of switching between biosimilar drugs and reference biologics on the management of RA patients (systematic review 2).Methods Electronic searches will be performed through MEDLINE (via Pubmed), EMBASE, LILACS, and CENTRAL (from inception to September 2020). Risk of bias assessments will be carried out with the Cochrane risk of bias tool, supplemented with specific domains from equivalence trials. Random-effects models will be fitted to obtain summary estimates using either relative risk or standardized mean difference as a metric. Between-trial heterogeneity will be tested and quantified with the Q-test and I2 metric, respectively, whereas assessment of small-study bias will be examined through contour-enhanced funnel plots and Egger and Harbord's tests. Meta-regression models will be fitted when appropriate. The primary outcome will be the rate of treatment success according to the American College of Rheumatology 20 (ACR20) and the co-primary outcome will be the Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index). Conclusions will be based on equivalence hypothesis testing using predefined margins of equivalence elicited from a group of experienced rheumatologists and prior studies. The overall certainty of evidence will be assessed based on the GRADE system.Discussion The two systematic reviews described here, to the best of our knowledge, are the first ones proposing a comprehensive, clinician-oriented approach to assess the equivalence and the impact of switching between biosimilars and biologics on the management of patients with RA. The results will elucidate the efficacy, safety, immunogenicity of biosimilars, and the clinical consequences of substituting biologics with biosimilars in the management of RA. Systematic Review Registration Protocol synopses were previously registered on PROSPERO (CRD42019137152 and CRD42019137155).

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Biosimilars in Developed Economies: Overview, Status, and Regulatory Considerations

Cited by 14 publications

References 15 publications

Analytical Similarity Assessment of Biosimilars: Global Regulatory Landscape, Recent Studies and Major Advancements in Orthogonal Platforms

Analytical Similarity Assessment of Biosimilars: Global Regulatory Landscape, Recent Studies and Major Advancements in Orthogonal Platforms

Changes in the Penetration Rate of Biosimilar Infliximab Within Japan Using a Japanese Claims Database

Equivalence and switching between biosimilars and reference molecules in rheumatoid arthritis: protocol for two systematic reviews and meta-analyses

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