The scope of GaBI Journal is broad and of interest and relevance to professionals active in clinical practice, pharmaceutical science and policy. Materials published in GaBI Journal include high quality research reports, literature reviews and case studies, all of which are peer reviewed.    Manuscripts on all aspects of generic and biosimilar medicines, covering areas in clinical, fundamental, technical, manufacturing, bi-processing, economic and social aspects of pharmaceuticals and therapeutics are welcome. In addition, high quality work submitted in other formats, for example, scientific and evidence-based commentaries, may also be considered. In all cases, the emphasis is on quality, originality and knowledge contribution to those involved in health care.    All manuscripts submitted to GaBI Journal are subject to a rigorous peer review process. GaBI Journal plans to be indexed in PubMed within two years, and that indexing will be retrospective.    GaBI Journal is published quarterly from 2012. All articles are published in English.

The GaBI Journal has a broad scope that is of interest and relevance to professionals engaged in clinical practice, pharmaceutical science, and policy. The materials published in the GaBI Journal include high-quality research reports, literature reviews, and case studies, all of which undergo rigorous peer review. We welcome manuscripts on all aspects of generic and biosimilar medicines, covering clinical, fundamental, technical, manufacturing, bioprocessing, economic, and social aspects of pharmaceuticals and therapeutics. Additionally, high-quality work submitted in other formats, such as scientific and evidence-based commentaries, may also be considered. In all cases, we emphasize quality, originality, and the contribution of knowledge to those involved in healthcare. All manuscripts submitted to the GaBI Journal are subject to a thorough peer review process. The GaBI Journal plans to be indexed in PubMed within two years, and this indexing will be retrospective. The GaBI Journal has been published quarterly since 2012, and all articles are published in English.

GaBI Journal 的范围广泛，涉及临床实践、药物科学和政策等领域，适合活跃于这些领域的专业人士。GaBI Journal 发表的材料包括高质量的研究报告、文献综述和案例研究，所有这些都经过同行评审。我们欢迎关于仿制药和生物类似药的各个方面的手稿，涵盖临床、基础、技术、制造、生物处理、经济和社会等药物和治疗的相关领域。此外，提交的高质量工作，如科学和基于证据的评论，也可能被考虑。在所有情况下，我们强调质量、原创性和对医疗保健相关人员的知识贡献。所有提交给 GaBI Journal 的手稿都将经过严格的同行评审过程。GaBI Journal 计划在两年内被 PubMed 收录，并且该收录将是追溯性的。GaBI Journal 自2012年起每季度出版，所有文章均以英语发表。

GaBI Journal

Abstract: The sky-rocketing cost of developing biosimilars is becoming a shared deterrent for biosimilar developers. The regulatory requirements for biosimilars must see a natural evolution and a paradigm shift towards removing inefficiencies in clinical designs to make way for cost-effective, sustainable development models. In this article, the authors provide a few suggestions that can lead to leaner and faster clinical development of biosimilars in the regulated market, and further across the globe, while not compromising the scientific validity of their development.

Sandeep N Athalye

Shivani Mittra

Ankitkumar M Ranpura

Generics and Biosimilars Initiative Journal

Biosimilars drug development: time for a paradigm shift?

生物类似药开发：是否到了范式转变的时刻？

This issue of the GaBI Journal contains only a limited number of articles, but these include two scientifi c very data-rich articles and an interesting and important expose on the use and misuse of products to treat COVID-19 patients. All three articles have potentially major implications for the global struggle to deal with the current COVID-19 pandemic; either with respect to the proper use of biosimilar products to safely reduce COVID-19 related and non-related pharmaceutical expenditures, as well as to the effects of the pandemic on the criminal use and abuse of human and veterinary pharmaceuticals and other products, e.g. disinfectants.

Philip D Walson

Fourth and final issue of GaBI Journal’s 10th volume

GaBI期刊第10卷第4期（最后一期）

The first GaBI Journal issue of 2022 comes at a time of both hope and despair. While the COVID-19 pandemic continues to cause significant global morbidity and mortality; especially in resource-poor countries, both the pace and direction of changes are beginning to produce some encouraging signs. Positive trends are in part the result of the continuing increase in our understanding of the virus itself, its treatment, and public health actions that are effective in limiting its spread. The availability of highly effective vaccines, antibodies, and antiviral medications have greatly limited infections and improved outcomes. Biological products, both innovator and biosimilar versions, as well as generic drug products are decreasing treatment costs and increasing the availability of effective treatments. Of special note is the increasing ability of resource-poor nations to produce their own versions of innovator products without patent constraints. Perhaps the most impressive example of this is, ‘The World’s COVID-19 ­Vaccine’ developed by the Texas Children’s Hospital at Baylor University and funding support of the Bill and Melinda Gates Foundation. This partnership has demonstrated that it is possible to overcome availability issues inherent in the for-profit pharmaceutical industry.

First 2022 GaBI Journal issue highlights

2022年GaBI期刊首期亮点

Study objectives: The increasing number of long-acting insulin analogues makes it difficult for general practitioners to have sufficient knowledge of each individual insulin formulation and device. Reducing the number of different insulin analogues used, based on rational criteria, allows physicians and pharmacists to build experience with a more limited set of medicines and to optimize patient information. The costs of newer formulations also need to be considered. Methods: In this study long-acting insulin analogues are compared by means of the System of Objectified Judgement Analysis (SOJA) method. The following selection criteria were applied: effectiveness, safety, tolerability, ease of use, and applicability. Concrete sub-criteria for each selection criteria were defined. Results and Conclusions: We found almost identical scores for the long-acting insulin analogues. Therefore, acquisition cost and individual patient characteristics should be used to determine the choice of formulary products. Glargine 100 IU/mL (biosimilar or originator) is the cheapest option in most cases. It should be noted that ‘good old’ Neutral Protamine Hagedorn (NPH) insulin is still a good treatment option from a formulary perspective NPH insulin is also likely to be cheaper than biosimilar glargine in most countries.

Robert Janknegt

Marloes Dankers

Long-acting insulin analogues. Drug selection by means of the System of Objectified Judgement Analysis (SOJA)

长效胰岛素类似物。通过对象化判断分析系统（SOJA）进行药物选择

Systematic clinical switch studies to demonstrate interchangeability of biosimilars are required in some jurisdictions while theoretical considerations and current clinical data question the feasibility and relevance of such studies.

Pekka Kurki

No need for systematic switch studies to demonstrate interchangeability of biosimilars

无需系统切换研究即可证明生物类似药的可互换性

Introduction: In Chile, access disparities and budget constraints affect the treatment of non-Hodgkin lymphoma patients, even though therapies like rituximab are covered by the Regime of Explicit Health Guarantees. Biosimilars like Rixathon® off er a compelling alternative with similar efficacy at lower cost. This study conducted a budget impact analysis to assess the introduction of Rixathon® for follicular lymphoma (FL) and diff use large B-cell non-Hodgkin lymphoma (DLBCL) patients from Chilean healthcare system perspective. Methods: A budget impact model was developed to estimate the cost difference between the actual scenario and a scenario considering greater Rixathon® coverage over a five-year period. Annual population was estimated based on rituximab sales data from 2015–2022 adjusted with corresponding factors. This study focused on differences in the total sum of acquisition and administration costs. Several scenarios were developed and analysed, including time-driven activity-based costing (TDABC) to estimate administration costs. Results: The projected population increases from 1,274 to 1,297 individuals for 2023–2027. Scenario 1 demonstrated that Rixathon® generated net cost savings of US$208,553 in 2023, or US$6,728 per patient, potentially enabling 49 additional patients to access Rixathon®. Similar trends are observed in Scenarios 2 and 3. The TDABC analysis revealed that the increment in administration costs were offset by the savings achieved through Rixathon® acquisition. Conclusion: Incorporating Rixathon® for FL and DLBCL patients was associated with savings in acquisition costs and its coverage could be extended to more patients. Administration costs resulted in a marginal incremental cost that was offset by the biosimilar net savings.

Tomás Abbot

Nicolás Armijo

Robin Piron

Manuel Espinoza

Budget impact analysis of a rituximab intravenous biosimilar in patients with follicular lymphoma and large B-cell non-Hodgkin lymphoma in Chile

利妥昔单抗静脉生物类似药在智利滤泡性淋巴瘤和大B细胞非霍奇金淋巴瘤患者中的预算影响分析

Introduction: Healthcare providers often lack familiarity with the concepts surrounding the biosimilars industry and the evidence required to support biosimilar development. This paper assesses current understanding, knowledge and perception of biosimilars in different specialties, with the aim of encouraging greater uptake. Methods: The authors assess factors that may impede the acceptance of biosimilars in the medical community and explore measures to enhance confidence. This was achieved with a search of the published literature and preliminary results of an online survey conducted by the authors amongst physicians across different specialities. Results: Even in established biosimilar markets, understanding of biosimilar specific terms such as switching and extrapolation is variable and knowledge of evidence required for biosimilar development and approval is lacking and/or outdated. Lack of familiarity with these concepts and the evidence required to support biosimilar development may deter healthcare providers from using biosimilars to their full advantage. More education for healthcare professionals is required in therapeutic areas where biosimilars are prescribed, and this should be updated regularly in step with evolving regulations. Conclusion: The successful adoption of biosimilars worldwide will require the continuing education of all healthcare professionals and stakeholders. This should include information on totality of evidence and data required for regulatory approval pathways, as well as clinically relevant concepts and terms. Lessons learned in established biosimilar markets and disease areas, such as oncology and immunology/rheumatology, can be shared with other countries and across different therapeutic areas to help prepare the market for new biosimilar entrants.

Andriy Krendyukov

Marta Bakowska

Dirk Schiller

Sanjay Singhvi

Current understanding, knowledge, and perception of biosimilars in a changing landscape of regulatory requirements

监管要求变化背景下对生物类似药的当前理解、知识和认知

The US Food and Drug Administration (FDA) proposed eliminating the distinction between biosimilars and interchangeable biosimilars, aiming to align with European policy and enhance biosimilar uptake. However, this move is misguided, as biosimilars diff er from generics and require individualized treatment plans. Physician confidence in biosimilars remains high, and the interchangeable standard has effectively built trust. Additionally, biosimilar uptake is influenced by formulary design, not interchangeability. Targeting pharmacy benefit managers practices could better support biosimilar adoption.

Michael S Reilly

Preserve the US interchangeable standard that has helped drive physician and patient confidence in biosimilars

维护推动医生和患者对生物类似药信心的美国可互换标准

It was with great pleasure that I assumed the role of Editor-in-Chief (EiC) of GaBI Journal in January of this year. Taking over the helm from Professor Philip D Walson is a considerable challenge; Phil’s excellent, thorough example will be very difficult to follow. My experience is restricted largely to biosimilars with which I have been involved since their concept and I will be relying on able colleagues for their expertise with generics! I hope to be able to carry out the important job of EiC effectively and efficiently.

Robin Thorpe

First 2024 GaBI Journal issue highlights

2024年GaBI期刊首期亮点

In principle, biosimilars could mitigate the problem of the rising cost of biological medicines. However, the current stringent and non-harmonized regulatory practices hinder competition and contribute to the high price level of biosimilars. The quality, safety, and efficacy of biosimilars developed, according to the current guidelines of ‘stringent’ regulatory agencies have proven to be excellent. Analytical and in vitro functional testing combined with clinical pharmacokinetic and pharmacodynamic studies provide the essential data to prove the similarity of candidate biosimilars to their reference products. The standard in vivo non-clinical toxicological studies are useless, and the value of ‘confirmatory’ controlled efficacy (and safety) trials have been questioned by several independent retrospective studies of current biosimilars, including monoclonal antibodies and fusion proteins. Thus, the development of biosimilars could be streamlined to lower costs without increasing risks to efficacy or safety of products. The UK regulatory agency, Medicines and Healthcare products Regulatory Agency (MHRA), and the World Health Organization (WHO) have recently revised their biosimilar guidelines to allow the development of biosimilars without ‘confirmatory’ clinical efficacy studies when the biosimilar candidate can be thoroughly characterized and shown to be structurally and functionally similar to the reference product that has no unpredictable serious adverse effects. The European Medicines Agency (EMA) is already exploring possibilities to revise its guidance accordingly. Unfortunately, the US Food and Drug Administration (FDA) is still hesitating. The US guidance should be revised to remove the interchangeability studies and reduce the controlled efficacy trials. Otherwise, the global biosimilar market will not be able to provide better access to biological medicines.

Abbreviation	GaBI J.
Journal Impact	0.25
Quartiles(Global)	PHARMACOLOGY & PHARMACY(Q4)

ISSN	2033-6403, 2033-6772
h-index	15

Publication Information	Publisher: Pro Pharma Communications International，Publishing cycle: ，Journal Type: journal，Open Access Journals: No
Basic data	Year of publication: 2014，Proportion of original research papers: 0.00%，Self Citation Rate:0.00%， Gold OA Rate: 3.33%

GaBI Journal

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