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.

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.

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 naïve 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.

Yerlika Biopharma is a pioneering biotechnology company in Turkey. Company CEO, Hasan Zeytin, MD, PhD, spoke to GaBI (Generics and Biosimilars Initiative) about the company’s strategic focus. Yerlika is dedicated to reducing the country’s dependency on imported biological products through localizing biopharmaceutical production in Turkey. With state-of-the-art manufacturing facilities, the company also aims to expand its global presence. Yerlika specializes in developing and producing biologicals, including biosimilars, monoclonal antibodies, gene therapies, and vaccines, positioning Turkey as a competitive hub for biotechnology innovation.

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.

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.

Study objectives: To determine the physicochemical stability of Gemcitabine Accord 100 mg/mL concentrate in original vials after first opening and after dilution with 0.9% sodium chloride solution in polyolefine (PO) bags at concentrations of 0.1 mg/mL and 10 mg/mL. Methods: Test solutions were aseptically prepared with Gemcitabine Accord 100 mg/mL and stored without protection from light at room temperature for up to 84 days. Samples were taken and analysed initially and at predetermined time points. Analyses comprised pH measurement, visual inspection and high-performance liquid chromatography (HPLC) assay. Results: Gemcitabine Accord 100 mg/mL concentrate in punctured vials remained physicochemically stable for 28 days when stored at room temperature without light protection. Gemcitabine diluted with 0.9% sodium chloride solution and stored in PO bags at room temperature under ambient light conditions remained physicochemically stable over the observation period of 84 days, irrespective of the gemcitabine concentration (0.1 mg/mL, 10 mg/mL). Conclusion: Gemcitabine Accord 100 mg/mL remaining solution in punctured vials can be used for up to 28 days when stored at room temperature without light protection. Diluted gemcitabine solutions in the concentration range of 0.1 mg/mL to 10 mg/mL can be prepared in advance and used over a period of 84 days, when stored in PO bags at room temperature.

Study objectives: To determine the physicochemical stability of Fluorouracil Accord 50 mg/mL solution for injection or infusion in three different types of elastomeric infusion pumps over 42 days, either undiluted (50 mg/mL) or after dilution with 0.9% sodium chloride or 5% glucose solution to concentrations of 0.1 mg/mL and 25 mg/mL. Methods: Test solutions were aseptically prepared with Fluorouracil Accord (5-FU) 50 mg/mL either transferred to Surefuser+ (Nipro), Easypump (B Braun), or Folfusor SV 2.5 mL/h (Baxter) elastomeric pumps. Test solutions were stored light-protected in the refrigerator (2°C–8°C) (0.1 mg/mL, 25 mg/mL 5-FU) and without light protection at 20°C–25°C (0.1 mg/mL, 25 mg/mL, 50 mg/mL 5-FU). At predetermined time points, storage conditions were changed, and test pumps kept for an additional period of 7 days at 30°C to simulate infusion conditions. Physicochemical stability was assessed by pH measurement, visual inspection and high-performance liquid chromatography (HPLC) analysis. Results: Physicochemical stability of undiluted and diluted Fluorouracil Accord in elastomeric infusion pumps was demonstrated for a 42-day storage at 2°C–8°C or at room temperature plus additional 7 days at 30°C. Conclusion: Fluorouracil Accord solutions in elastomeric infusion pumps may be prepared in advance and stored over a period of 42 days at room temperature (concentration range 0.1 mg/mL to 50 mg/mL 5-FU) or at 2°C–8°C (concentration range: 0.1 mg/mL to 25 mg/mL 5-FU) plus 7 days at 30°C.

The US biosimilar programme has been highly successful with 53 biosimilars approved by the US Food and Drug Administration (FDA) for 17 reference products. As in most advanced nations of Europe, all FDA-approved biosimilars may be substituted in place of the reference product by the physician. To be substitutable at the pharmacy level, however, US state law requires these to be FDA-approved as ‘interchangeable biosimilars’ – a designation earned through additional data showing no loss of safety or efficacy is expected even after multiple switches, relative to a patient who remained on the reference product. Thirteen biosimilars have earned this designation. FDA currently has the flexibility to determine how these data requirements are met; this can include switching studies, however, multiple interchangeable biosimilars have been approved without them. This data-driven approach has significantly bolstered physician and patient confidence in biosimilar safety and efficacy, particularly regarding pharmacy substitution. Yet there has recently been a push by policymakers at many levels of government to limit the types of data the FDA can consider, or otherwise lower the data requirements. The authors of this article critically examine a meta-analysis frequently cited by policymakers supportive of these efforts. They argue that the study’s conclusions – and the policy proposals – are unsupported by the data, which do not address efficacy impacts and extrapolate multi-switch safety despite a disproportionate reliance on single-switch studies. Rushing to dismantle proven standards based on these and other misconceptions, the authors argue, poses a potential risk to patient treatment stability and confidence in biosimilars. Preserving the quality standards that have defined the introduction of interchangeable biosimilars in the US, and the FDA’s flexibility to seek additional data when needed, will help ensure that patient care remains personalized and the integrity of the patient–physician relationship is maintained.

Study objectives: To determine the physicochemical stability of undiluted Irinotecan Accord concentrate in punctured original glass vials, in polypropylene (PP) syringes, and after dilution with 0.9% sodium chloride solution or 5% glucose solution in polyolefine (PO) bags at different concentrations and storage conditions for up to 96 days. Methods: Test solutions were prepared with Irinotecan Accord 20 mg/mL and stored refrigerated with light protection and at room temperature under normal room light (undiluted solutions) or at room temperature (20°C–25°C) with light protection (diluted solutions). Samples were taken and analysed initially and at predetermined time points. Analysis comprised pH measurements, visual inspections and high-performance liquid chromatography (HPLC) assays. Results: Irinotecan concentrate in punctured vials remained physicochemically stable for 56 days and 14 days, when stored refrigerated under light protection or at room temperature under ambient light conditions, respectively. Irinotecan concentrate stored in PP syringes remained stable for up to 96 days when stored at room temperature. Diluted irinotecan solutions stored in PO bags at room temperature remained physicochemically stable for up to 84 days, independent from the vehicle solution. Conclusion: Irinotecan Accord 20 mg/mL residues in punctured vials can be used for up to 56 days when stored refrigerated and for 14 days when stored at room temperature or for 96 days in PP syringes, when stored at room temperature without light protection. Diluted solutions may be prepared in advance and used over a period of 84 days, when stored in PO bags at room temperature.