A new insurance-backed financing model for biosimilars uses AI-powered underwriting to cover clinical trial costs if they fail. This reduces risk, improves capital access, and minimizes equity dilution for developers.
This editorial discusses systemic barriers limiting oncology biosimilar adoption in Chile and Latin America, emphasizing trust, education, and coordinated policy actions to strengthen value, equity, and confidence in biosimilars.
In this first issue of 2025, we have some controversial criticism of an article previously published in GaBI Journal [1}, as well as a paper on pricing of biosimilars/biologicals after patent expiry and a meeting report on claimed weakening of FDA regulatory standards for biosimilars and its perceived effects on undermining physician confidence in biosimilar products. The issue contains no articles on chemical generics, and we encourage potential authors to submit papers to GaBI Journal on this very important class of product, as well as articles on biosimilars.
Rieger and Holland provided a report of a stakeholder meeting dealing with the biosimilar uptake in Australia. The proposed policy measures reported may not have a dramatic effect on the biosimilar uptake.
In this second issue of 2025, we have a diverse spectrum of publications which include one original research paper in the generics area and biosimilar-focused articles which comprise one special report, one meeting report, one interview and one sponsored article.
The critique of Reilly and McKibben of the meta-analysis conducted by Herndon et al. is factually flawed on several important points. As a result, the conclusions of Reilly and McKibben are not scientifically substantiated.
Reilly and McKibbin oppose the update of FDA interchangeability guidance that does not require clinical switch studies. However, their arguments lack a scientific basis.
Introduction/Study objectives: Given that the purified micronized flavonoid fraction (diosmin/hesperidin 450 mg/50 mg) is a formulation with low water solubility, granulated form, and low intestinal membrane permeability, the present bioequivalence study was conducted to compare Dipemina (R) (T: tested) with Daflon (R) (R: reference product). Methods: A phase I, open-label, randomized, two-period, two-treatment (2x2) crossover study was carried out in fasting adult participants. A total of 56 participants were enrolled, with only one subject not completing the study. Participants followed a diet free of citrus juices from the screening phase through to study completion. Results: Regarding participant characteristics: the mean age was 24 +/- 5 years, the mean body weight was 69 +/- 10 kg, the mean height was 1.66 +/- 0.10 m, and the mean body mass index was 24.93 +/- 2.66 kg/m2. No statistically significant differences were observed in the following parameters: Cmax: 1079 +/- 365 vs 1102 +/- 350 (pg/mL), AUC0-72: 28,417 +/- 9181 vs 28,049 +/- 9121 (pg & centerdot;h/mL), and Tmax parameters (LnAUC0-72: 1.009, CI: 0.957 to 1.064, and LnCmax: 0.975, CI: 0.934 to 1.017, respectively) remained within the accepted bioequivalence range of 0.8 to 1.25, including the 90% confidence interval. Conclusion: In summary, therapeutic bioequivalence was demonstrated between the new generic formulation (Dipemina (R)) and Daflon. : 2.17 +/- 0.87 vs 2.20 +/- 0.74 (h) between Tand R products. The T/R ratio of the logarithmically transformed pharmacokinetic
Introduction/Background: Biosimilar medicines represent an opportunity to expand access to medicines and reduce costs for payers through increased uptake. Australia is not fully capitalising on this opportunity relative to other Organisation for Economic Co-operation and Development (OECD) countries, reflected in comparisons of biosimilar medicines uptake by other OECD countries. Understanding of international examples can help to shape policy measures in Australia. Methods: A literature review and Australian and international policy scan were conducted using MEDLINE, Google Scholar, Pharmaceutical Benefits Scheme (PBS) literature and reports, local association literature and reports, OECD biosimilar uptake reports, and grey literature to inform the stakeholder summit meeting in early 2025. References were selected based on relevance to Australia-specific biosimilar uptake policy drivers, comparable biosimilar uptake data, and policy drives applied in comparable markets. Results: Discussions focused on several key goals: reducing costs and increasing benefits for patients, reduced administrative burden for clinicians, and removing barriers to the use of biosimilars in Australia. There was consensus that significant barriers exist. These include a lack of effective policy drivers for clinicians and patients, insufficient integrative education for patients and healthcare professionals (HCPs), and current policies that hinder uptake. Furthermore, existing mechanisms-such as recommending biosimilars for treatment-na & iuml;ve patients, allowing pharmacy substitution, and having only slight differences in written authority requirements between reference biologicals and biosimilars-are insufficient to overcome these barriers. The discussion also covered the effective implementation of proposed policies, with a specific focus on easing access to medicines and creating efficiencies for patients, clinicians, and pharmacists. Summit attendees agreed that any savings generated through such policies should be transparently repurposed for key healthcare initiatives. This transparency is crucial so that HCPs and patients understand how their adoption of biosimilar medicines leads to broader improvements in care and access. Conclusions: With increasing use of biological therapies on the horizon, Australia must learn from the successful strategies implemented in other countries to ease the growing burden of healthcare spending in Australia and to ensure sustainability of the PBS.
Introduction: In the US, some biosimilars that meet additional requirements may be approved as interchangeable products. This means they can undergo pharmacy-level substitution. An online webinar titled 'Biosimilar Red Tape Elimination Act (S.2305): Weakening FDA Regulatory Standards for Biosimilars, Undermining Physician Confidence and Jeopardizing Patient Health', was held to discuss its implications on medicines availability, safety and efficacy. It highlighted that the bill would class all biosimilars as interchangeable. Methods: The webinar was held by the Alliance for Safe Biologic Medicines (ASBM) in collaboration with the Generics and Biosimilars Initiative (GaBI) on 31 October 2024. A number of expert speaker presentations were followed by a Q&A with the panel, and the audience also had the opportunity to ask questions online throughout the webinar. Results: Presentations examined the current status of biosimilars and interchangeable biosimilars in the US, highlighting contrasts with Europe. The results of a recent prescriber survey on biosimilars and confidence in their use were outlined. The Biosimilar Red Tape Elimination Act (S.2305) was also presented and discussed. Perspectives from physicians, pharmacists, regulators, and patients on the legislation were explored, and shortcomings of the bill were highlighted. Additional details from the presentations were addressed during the Q&A session. Conclusion: The webinar facilitated an in-depth discussion about Biosimilar Red Tape Elimination Act and highlighted its shortcomings, particularly regarding the designation of all biosimilars as interchangeable.
Introduction: Chorioretinal vascular diseases are among the leading causes of irreversible blindness in industrialized countries. The prognosis of chorioretinal vascular diseases has been largely improved with the introduction of the vascular endothelial growth factor (VEGF) inhibitors, biological drugs which have become the first line therapy for patients with these conditions. The development of biosimilars may improve access to such biological medicinal products while reducing the healthcare costs. Study objectives: This study aimed to demonstrate effective and safe handling of AVT06 pre-filled syringe (PFS) administered to study participants with chorioretinal vascular diseases. The primary objective was to evaluate the proportion of successful administrations of AVT06 after a single administration with PFS. The secondary objective of the study was to evaluate ocular safety after a single dose of AVT06 delivered with PFS. Results: The proportion of successful injections after a single administration of AVT06 PFS was 100%, demonstrating the intended and safe handling by the physicians. The AVT06 administered with PFS was found to be safe and well-tolerated in participants with chorioretinal vascular disease without any clinically significant safety findings related to the study treatment. No serious adverse events (SAEs) or adverse events (AEs) leading to discontinuation were reported, as well as no treatment-related treatment emergent AEs. Two participants were reported with adverse events of special interest (AESIs) up to end of study, neither of them was related to the study treatment. Discussion and Conclusion: This study demonstrated intended and safe handling of AVT06 PFS by the intended users. The intravitreal injection of AVT06 administered with PFS was safe and well tolerated during the treatment of chorioretinal vascular disease.
Introduction and Study objectives: Despite their well-established potential to reduce healthcare expenditures, biosimilars have not achieved widespread adoption in Chile, particularly in oncology. The lack of regulatory incentives and reimbursement frameworks only partially explains this phenomenon. This study aims to identify key barriers to biosimilar adoption in the Chilean healthcare system and propose strategic recommendations to strengthen their value proposition. Methods: The analysis integrates Michael Porter's value chain model with qualitative methods. Eight strategic activities in the pharmaceutical sector were explored: Regulatory approval, local approval, health technology assessment (HTA), financial coverage, medical education, prescription, purchasing, and adherence. Nineteen in-depth interviews were conducted with hospital-based professionals, patients, and policymakers using semi-structured and convergent techniques. Triangulation, saturation, and snowball sampling ensured methodological rigour and comprehensive stakeholder representation. Results: While a few barriers were noted for initiating treatment in na & iuml;ve patients, substantial challenges exist regarding switching, particularly due to outdated regulatory norms. HTA for biosimilars remains low on the policy agenda. Stakeholders emphasized misinformation, low medical confidence, lack of economic evidence, limited incentives, and weak stakeholder engagement. Negative perceptions of quality and clinical efficacy persist. The industry's low visibility further hinders uptake. We propose a five-dimensional framework-scientific evidence, medical education, economic evidence, stakeholder engagement, and communication to improve the value proposition of biosimilars. Discussion: Barriers are multifactorial and systemic, requiring coordinated, multisectoral responses. Individual efforts are insufficient to drive meaningful change. Conclusion: This approach serves as a roadmap to enhance the value proposition of biosimilars, promote equitable access and fiscal sustainability in cancer care.
Introduction/Study objectives: A biosimilar is a biological medicine that is developed to be similar to an existing biological medicine (the 'reference medicine') for which marketing exclusivity rights have expired. The prices of such medicines are shaped by regulations on pharmaceutical pricing, or the policy of setting the price of a medicine at certain points in the pharmaceutical distribution chain as well as wholesalers' and pharmacists' remuneration margins and product taxation. The aim of this study is to assess how different national policies concerning pharmaceutical pricing and the reimbursement of medicines in European countries impact the pricing of-and, consequently, also access to-biosimilars. Methods: A difference-in-differences (DID) approach was developed in which relative prices were modelled as a function of selected pharmaceutical policies (price link, prescribing by international non-proprietary name, substitution at pharmacies and inclusion into reference pricing system), while accounting for effects related to characteristics of the product and country characteristics, as well as the number of available biosimilars as an approximation of competition. Data on monthly prices of nine biological active ingredients (adalimumab, enoxaparin, etanercept, infliximab, insulin glargine, insulin lispro, pegfilgrastim, rituximab, trastuzumab) were collected. In addition to price information, data on: (a) medicines; (b) policy measures; and (c) other characteristics of examined countries was gathered. Results: The model reveals decreasing average prices of biological medicines after the entry of biosimilars on the market. Different alterations of the model show that the most significant driving factors of price developments are supply-side measures, mainly regulating maximum prices through price links, as well as the entrance of more biosimilars of a pharmaceutical presentation on the respective market and the number of periods at which a biosimilar is available. For the demand-side policies International Nonproprietary Name (INN) prescribing, biosimilar substitution, and reference price system) neither consistent nor significant effects on prices were identified. Conclusion: The results highlighted the significant impact of supply-side pricing policies, whereas demand-side measures did not foster a more competitive environment for biological medicines and have yet not led to substantial price reductions.
In December 2023, the University of Helsinki, Helsinki University Hospital (HUS), and University Pharmacy (Yliopiston Apteekki) Helsinki collaborated to present the online symposium titled 'Current Trends in Biosimilar Uptake and Research with Special Focus on Automatic Substitution'. This provided an overview of global trends in biosimilar use and a systematic examination of the implications of automatic substitution for diverse stakeholders. The symposium proceedings, along with relevant updates, are presented in this paper.
In Brazil, the legal framework for approving biosimilars was established in 2010 and the first biosimilar product was approved in 2015. In June 2024, RDC 875 introduced new provisions, including the use of international reference drugs and the possibility of waiving non-clinical and comparative clinical studies under certain conditions. By September 2025, ANVISA had approved 67 biosimilars, ensuring high standards of quality, safety, and efficacy.
In light of recent global health challenges, the need for regulatory reliance – where one regulatory authority accepts the decisions of another – has gained significant interest and momentum. A fundamental role of any government is to protect its citizens and promote a healthy lifestyle by ensuring the quality, safety, and efficacy of medical products. This task can be challenging for governments, national regulatory authorities, and inspectorates due to shortages of competent staff, inadequate resources, and varying levels of political and regulatory will. The World Health Organization (WHO) is a specialized agency of the United Nations responsible for international public health. The WHO Constitution states its main objective as ‘the attainment by all peoples of the highest possible level of health’. Headquartered in Geneva, Switzerland, it has six regional offices and 150 field offices worldwide. The WHO Prequalification Programme, established in 2001, is a service provided by WHO to facilitate access to medicines that meet unified standards of quality, safety and efficacy for HIV/AIDS, malaria and tuberculosis. From the outset, the Programme has been supported by the Joint United Nations Programme on HIV/AIDS (UNAIDS), United Nations International Children’s Emergency Fund (UNICEF), United Nations Population Fund (UNFPA), and the World Bank as a concrete contribution to the United Nations’ priority goal of addressing widespread diseases in countries with limited access to quality medicines. According to WHO, in good reliance practices in the regulation of medical products: high-level principles and considerations (TRS 1033, Annex 10): Regulatory reliance is an act by the National Regulatory Authorities (NRAs) around the globe to take into account the outcome of a regulatory decision from a competent authority before reaching their own decision to approve or reject certain applications for marketing authorizations. Regulatory recognition is a process whereby a regulatory decision is made by an NRA based on the evidence of conformity provided by another competent and matured NRA, without reinventing the wheel (WHO TRS 1019, Annex 6). This paper reviews and evaluates initiatives undertaken (from 1980) by various NRAs and regional and international organizations to leverage regulatory reliance and regulatory recognition to harmonize regulatory decisions and expedite the regulatory approval process.
This third issue of GaBI Journal is the last of the volume for this year and marks the end of the first year of me taking up the Editor-in-Chief position for the journal. We have seen a very considerable variety of papers submitted and published during 2024.
Non-communicable diseases (NCDs) disproportionately affect people living in low- and middle-income countries (LMICs) compared to high-income countries (HICs). Given the particularly limited healthcare resources in LMICs, increasing the adoption of biosimilar products can be a viable solution to expand access to medicines. Biosimilars can allow patients to be treated with more affordable biologic products compared to their originator biologics. As most of the literature around biosimilars focuses on HICs, this review article offers insights into the benefits of biosimilars for better access to biologics in LMICs, focusing on data from selected emerging markets. Insights were mainly gathered via conducting interviews in LMICs on exploring challenges towards access to biosimilars and were supplemented with a literature search. This review article highlights the burden of NCDs in LMICs, trends in the regulatory space for biosimilars, benefits of biosimilars, and challenges in accessing biosimilars in emerging markets. The challenges include weaker regulatory frameworks, dependence on importation, low awareness of biosimilars, and the need for effective policies encouraging access to and use of biosimilars. This review article suggests recommendations to increase access to and adoption of quality-assured biosimilars in LMICs, including strengthening regulatory and pharmacovigilance systems, providing guidance on prescribing biosimilars and education on biosimilars, strengthening national policies to increase adoption of biosimilars, encouraging local manufacturing, and encouraging stakeholders’ initiatives promoting access to biosimilars. Acknowledging that affordability remains a main factor for stakeholders’ purchasing decisions, this paper offers additional criteria beyond price that may help stakeholders in LMICs select quality-assured biosimilars.
CinnaGen, the largest biopharmaceutical company in the MENA region, is a leader in developing follow-on biologicals/biosimilars. Dr Haleh Hamedifar, Chairperson of CinnaGen, spoke to GaBI (Generics and Biosimilars Initiative) about the company’s strategic focus, which includes expanding its product portfolio, entering highly regulated global markets, and advancing affordable treatments for conditions such as multiple sclerosis and immunological diseases—transforming health care in underserved regions.
This paper examines the repercussions of recent quality and regulatory crises in Japan’s generic pharmaceutical sector, focusing on incidents involving Sawai Group Holdings (Sawai GHD) and other manufacturers. It provides a comprehensive analysis of the consequences stemming from lapses in good manufacturing practice (GMP) compliance, particularly highlighted by the case of teprenone capsules 50 mg ‘Sawai’ where stability monitoring was found deficient. These lapses have impacted manufacturers like Sawai GHD, leading to the resignation of their head of quality assurance. Additionally, these issues have caused significant healthcare disruptions due to forced drug recalls and substitutions, further strained by existing drug shortages. The study highlights the broader context of Japan’s pharmaceutical landscape, including government policies aimed at boosting generic drug use to mitigate healthcare expenses in one of the world’s most aged societies. Despite these efforts, the study illustrates that intense price competition and regulatory pressures have led to financial strains and a focus on cost-cutting measures, often at the expense of product quality and supply stability. The repercussions have been profound, leading to public and professional distrust in generics, which has been exacerbated by a series of controversies, such as the contamination incident involving Kobayashi Kako Co, Ltd in 2021. Drawing on comparisons with global trends, particularly the German market, the study argues for the need to reassess Japan’s healthcare policies, advocate for sustainable pricing models, and emphasize rigorous quality oversight to restore confidence in the generic drug sector. It calls for strategic reforms to reconcile cost containment with quality and supply chain stability, ensuring the pharmaceutical industry can meet both domestic and international healthcare demands effectively.
