Bridging the global health equity gap: the impact of local biological manufacturing on patient access in Iran
Published on 04 May 2026
Generics and Biosimilars Initiative Journal (GaBI Journal). 2026;15(2).
Introduction/Study Objectives: Biological therapies have revolutionized the treatment of cancers, autoimmune, and metabolic diseases. However, access to these life-saving treatments remains severely limited in low- and middle-income countries due to high costs and infrastructure deficits. This study evaluates the impact of local manufacturing of biosimilars and complex biologicals on patient access in Iran, a lower-middle-income country under economic sanctions. |
Introduction/Study objectives
In recent years, the advent of biological therapies has fundamentally transformed the treatment paradigm for a wide array of conditions, including malignancies, autoimmune disorders, and metabolic diseases, establishing new standards of care globally. However, a significant disparity exists in the availability of these innovative treatments across geographic regions and socioeconomic status. In low- and middle-income countries (LMICs), access to biologicals remains severely restricted. The primary barriers to widespread adoption in these regions include deficiencies in healthcare infrastructure and regulatory frameworks, limited domestic manufacturing capacity, and a heavy reliance on pharmaceutical imports [1, 2]. Consequently, the high cost of imported biologicals, coupled with the limited financial resources of insurance systems and national health budgets, results in prohibitive out-of-pocket costs for patients [1]. This dynamic deprives a substantial portion of patients in developing nations of standard, effective treatments, thereby creating a profound gap in global health equity.
The context of the Islamic Republic of Iran presents a unique scenario within this global landscape. According to World Bank classifications, Iran is categorized as a lower-middle-income country [3]. Furthermore, in 2025, reports from the International Monetary Fund (IMF) rank Iran approximately 132nd globally in terms of gross domestic product (GDP) per capita [4, 5]. Beyond these macroeconomic indicators, decades of economic sanctions and international restrictions have historically impeded the country’s access to advanced medical technologies and novel therapeutics.
Despite these significant constraints, the domestic pharmaceutical sector has pursued a strategy of self-reliance. CinnaGen, a leading knowledge-based biopharmaceutical company, has successfully leveraged local scientific expertise to manufacture a broad spectrum of complex biologicals. This localization strategy aims to decouple patient access from external economic pressures. The objective of this paper is to analyse how the domestic production of biosimilars and novel biologicals has enabled Iran not only to outperform its economic peers in specific therapeutic areas but also, in certain instances, to approach or exceed treatment access standards observed in developed nations. We examine this impact across four key therapeutic categories: immuno-oncology, paediatric endocrinology, rheumatology, and neurology.
Methods
Study design and data sources
We conducted a retrospective descriptive study to evaluate the trends in patient access to biological therapies in Iran following the introduction of locally manufactured biosimilars and novel biologicals. The analysis focused on four primary therapeutic areas: oncology (immunotherapy), paediatric endocrinology (growth disorders), rheumatology (autoimmune diseases), and neurology (multiple sclerosis).
Data regarding national pharmaceutical consumption and patient numbers were extracted from the official pharmaceutical statistical yearbooks published by the Iran Food and Drug Administration (IFDA) covering the period from 2012 to late 2025 [6]. These datasets are publicly accessible in Iran.
Patient support and adherence data
All patient data extracted from the OrchidLife database—a dedicated patient support programme (PSP) established by CinnaGen—were aggregated and de-identified to ensure patient confidentiality and compliance with privacy regulations. Complementary data regarding patient adherence, treatment persistence, and specific demographic coverage were obtained from the same source.
This database provided real-world evidence on the use of somatropin (CinnaTropin) and other biologicals, including more than 160,000 patients [7]. While IFDA data are in the public domain, OrchidLife PSP data are proprietary and available from the corresponding author upon reasonable request.
Comparator data and economic analysis
To benchmark the Iranian healthcare landscape against international standards, we compared domestic data with global and regional statistics.
Oncology: Access rates were compared with data from India [8] and the United Kingdom [9], utilizing eligibility criteria defined in recent studies [10].
Endocrinology: Treatment coverage and adherence rates for paediatric growth hormone deficiency (pGHD) were compared with data from the United States [11, 12].
Rheumatology: The consumption of anti-tumour necrosis factor (anti-TNF) agents was compared with regional data from Turkey and global estimates [13, 14].
Neurology: Data on multiple sclerosis (MS) high-efficacy therapies were benchmarked against the Atlas of MS and reports from Europe and the US [15, 16].
Economic comparisons utilized GDP per capita and purchasing power parity (PPP) data from the International Monetary Fund (IMF) and World Bank to contextualize the affordability of treatments relative to the country’s economic standing [3-5, 17, 18]. Cost-effectiveness values for immunotherapy were derived from local pharmacoeconomic studies [19].
Results
Expansion of immunotherapy access in oncology
Immunotherapy with biological agents, such as pembrolizumab, is indicated for approximately 44% of cancer patients [10, 20]. Before the domestic production of pembrolizumab in Iran, access was negligible; in 2022, only 29 patients received the imported originator. Following the 2022 launch of the biosimilar ZakAria (pembrolizumab) by CinnaGen, patient access expanded rapidly. Our analysis shows that ZakAria is offered at a highly affordable rate, representing 17% of the calculated cost-effective price threshold for the Iranian market [19]. This pricing strategy significantly lowered the barrier to entry. Based on IFDA reports, it is projected that by the end of 2025, more than 20,000 patients, representing 15% of the eligible population, will be treated with ZakAria [6], see Figure 1. Currently, ZakAria accounts for over 90% of pembrolizumab utilization in the country. This 15% access rate surpasses the 1.6% rate observed in India [8] and is comparable to the 13.5% treatment rate reported in the United Kingdom [9].
Improved coverage for paediatric growth hormone deficiency (pGHD)
The standard treatment for pGHD, estimated to affect 8–10 per 10,000 children [11], is recombinant human growth hormone. Since the introduction of the biosimilar somatropin (Cinna Tropin) in 2017, the treatment access rate in Iran has risen from 26% in 2016 to 75% in 2025 [6, 7], as shown in Figure 2.
This coverage rate exceeds the 65% treatment initiation rate reported in the US [12]. Affordability has been a key driver; the substantially reduced annual treatment cost allows public insurance schemes to cover more than 70% of the expenses [14]. Furthermore, the implementation of the OrchidLife patient support programme has supported over 160,000 patients over nine years, contributing to high adherence rates [7].
Transformation of rheumatology care with anti-TNF agents
Anti-TNF biological drugs are recognized as the gold standard for the treatment of many rheumatologic diseases, including psoriasis, rheumatoid arthritis, and inflammatory bowel disease (IBD), in moderate to severe forms of these conditions (21-23). Before local production of adalimumab, access to this anti-TNF therapy was severely limited. Between 2012 and 2015, only approximately 600 patients utilized the imported originator [6]. The launch of the biosimilar CinnoRA in 2016 marked a turning point.
Data from the first half of 2025 indicate that by year-end, more than 100,000 patients will be receiving CinnoRA, reflecting a 170-fold increase in access over one decade [6, 7], please see Figure 3. This coverage represents 15% of patients requiring biological therapy, compared with estimates of less than 5% in similar resource-constrained settings [13, 14]. A cost comparison with neighbouring Turkey reveals a significant disparity favouring the Iranian model. While the GDP per capita (PPP) in Turkey (US$43,786) is roughly double that of Iran ($21,473) [17, 18], the cost of adalimumab in Iran is approximately 20% of the cost in Turkey (US$115– US$120) [24]. Although this results in a smaller market value in dollar terms (US$26 million versus US$600 million), it substantially expands patient access.
High-efficacy therapies in multiple sclerosis (MS)
Iran has a high prevalence of MS, with over 86,000 diagnosed patients [15]. The availability of locally produced high-efficacy disease-modifying therapies (DMTs), particularly ocrelizumab (Xacrel) and rituximab (Zytux), has shifted the standard of care [25, 26]. According to the 2022 Atlas of MS report, 30% of Iranian MS patients receive high-efficacy biologicals, a rate higher than the global average (21%), Europe (23%), and the US (20%) [16], see Table 1.
Locally manufactured products (Xacrel and Zytux) account for approximately 80% of this high-efficacy segment. Specifically, the proportion of MS patients treated with ocrelizumab (Xacrel) has increased 2.5-fold, rising from 10% in 2022 to a projected 25% in 2025 [6], as shown in Figure 4. This broad access is supported by insurance coverage exceeding 90% for all patients [27].
Discussion
The findings of this study illustrate a distinct paradigm in global health: a lower-middle-income country, constrained by economic sanctions and limited financial resources, achieving patient access rates to cutting-edge biologicals that rival those of developed nations. This achievement challenges the prevailing narrative that advanced biological therapies are inevitably beyond the reach of developing healthcare systems due to their prohibitive costs [1, 2].
The primary driver of this expanded access is the dramatic reduction in treatment costs facilitated by local manufacturing. In the case of pembrolizumab, the domestic price is only 17% of the country’s calculated cost-effectiveness threshold [24]. This pricing strategy allows public insurance schemes to cover advanced therapies without bankrupting the health budget. Similarly, the pricing of adalimumab at one-fifth of the cost in neighbouring Turkey demonstrates how local production can decouple drug prices from regional trends, prioritizing patient volume over market value in dollar terms. Our data on MS and pGHD are particularly revealing. The fact that Iranian patients use high-efficacy MS therapies at rates exceeding those in Italy and the US [16] suggests that, when financial barriers are removed, clinical decision-making can align more closely with scientific best practices rather than economic constraints. This aligns with efforts to reduce global health inequities, ensuring that a patient’s geographic location does not dictate their quality of care. Beyond affordability, the role of the OrchidLife patient support programme highlights the necessity of a holistic ecosystem. Ensuring access to the drug is the first step; ensuring adherence through education and monitoring is what translates access into clinical outcomes. The high adherence rates in pGHD treatment [7] underscore the value of this integrated approach.
Limitations
It is essential to acknowledge that data for the full year of 2025 are projections based on six-month trends. While historical patterns suggest these projections are robust, actual year-end figures may vary slightly. Additionally, while quantitative access is high, future studies should focus on long-term clinical outcomes and pharmacovigilance data to further validate the quality of care.
Conclusion
The analysis of the Iranian pharmaceutical landscape reveals that the gap between middle-income and developed nations regarding access to advanced therapies is not an insurmountable, permanent divide. Our findings suggest that Iran’s success rests on four structural pillars that can serve as a scalable model for other emerging economies:
- Sustainable Local Production: Transitioning from import dependency to technology-driven domestic manufacturing has ensured a predictable supply chain, mitigating the impact of external shocks.
- Purchasing Power-Based Pricing: Establishing pricing strategies aligned with societal affordability, exemplified by significantly reducing the annual cost of growth hormone therapy, has been crucial.
- Extensive Financial Protection: Low acquisition costs have enabled government insurers to broaden coverage, reducing patients’ out-of-pocket expenditures to less than 10% in many cases.
- Integrated Data and Support Ecosystem: The establishment of the first data-driven Patient Support Programs (PSPs) for rare and chronic diseases in Iran has significantly improved compliance and treatment adherence.
This ‘Iran Model’ highlights a practical strategy for countries with similar economic profiles, such as Brazil, Egypt, India, Indonesia, and Pakistan, to overcome barriers to biological therapies. While long-term international integration requires alignment with global regulatory standards, this study demonstrates that local production can serve as a potent transitional tool for expanding patient access and improving health equity in resource-constrained settings.
In less than a decade, by fostering a cohesive biological ecosystem and trusting private sector leaders like CinnaGen, Iran has achieved milestones previously thought impossible for a developing nation: increasing immunotherapy access from negligible rates to 15%, expanding Anti-TNF utilization by 170-fold, and surpassing high-income countries in the adoption of high-efficacy MS therapies. Ultimately, this study demonstrates that local production is a potent tool for dismantling the global ‘treatment apartheid’ and ensuring health equity.
Authors’ comments
The strict regulatory guidelines of the Iran Food and Drug Administration (IFDA), the approval of any locally manufactured biological product mandates the successful completion of a phase III clinical trial. These trials directly compare the domestic product with the reference innovator brand to establish comparability in terms of quality, efficacy, and safety prior to granting market authorization.
Data control and availability
The authors declare that they had full access to all study data and take responsibility for the integrity and accuracy of the data analysis. The authors agree to allow GaBI Journal to review the data if requested.
For patients
Biological medicines are powerful treatments for cancer, autoimmune diseases, and growth disorders, but they are often too expensive for people in many parts of the world. This paper highlights how Iran has addressed this problem by producing these complex medicines domestically rather than importing them. By producing high-quality medicines locally, e.g. those by CinnaGen, the cost of treatment has decreased significantly, sometimes by more than 80%.
This cost reduction has allowed the government and insurance companies to help pay for these treatments, meaning thousands of patients who previously could not afford care now have access to the same standard of treatment as patients in Europe or the US. This study proves that living in a developing country should not mean settling for lower-quality healthcare; with local production and proper support, patients can access the best possible treatments.
Funding sources
This study was funded by CinnaGen.
Competing interests: Deyhim Atarod and Soheil Roshazamiri are employees of the Pipeline and Portfolio Management Department at Orchid Pharmed Co. Orchid Pharmed is the entity responsible for the sales and marketing of CinnaGen pharmaceutical products. Elmira Sayari is affiliated with the CinnaGen Medical Biotechnology Research Center. The analysis presented in this study was conducted using a synthesis of official pharmaceutical utilization data from the Iran Food and Drug Administration (IFDA) and proprietary raw data from the OrchidLife Patient Support Program. The authors declare that their professional affiliations and the commercial relationship between the two companies did not influence the integrity of the data analysis or the scientific objectivity of the conclusions.
Provenance and peer review: Not commissioned; externally peer reviewed.
Authors
Soheil Roshanzamiri1, PharmD, iBCPS
Deyhim Atarod1, PhD in Biochemistry
Elmira Sayari2, PharmD
1Orchid Pharmed Company, No. 42, Attar Street, Attar Square, North Kurdistan Highway, 1994766411 Tehran, Iran
2CinnaGen Medical Biotechnology Research Center, Alborz University of Medical Sciences, R2V4+2VX Hassan Abad, Karaj, Alborz Province, Iran
References
1. Morin S, Segafredo G, Piccolis M, Das A, Das M, Loffredi N, et al. Expanding access to biotherapeutics in low- and middle-income countries through public health, non-exclusive, voluntary intellectual property licensing: considerations, requirements, and opportunities. Lancet Glob Health. 2023;11(1):e145-54.
2. Wouters OJ, Kuha J. Low- and middle-income countries experienced delays accessing new essential medicines, 1982-2024. Health Aff (Millwood). 2024;43(10):1410-19.
3. World Bank. World Bank country classifications by income level for 2024- 2025 [Internet]. Washington (DC): World Bank Group; 2024 [cited 2026 Apr 18]. Available from: https://blogs.worldbank.org/en/opendata/ world-bank-country-classifications-by-income-level-for-2024-2025
4. International Monetary Fund. World Economic Outlook (October 2025). GDP per capita, current prices [homepage on the Internet]. [cited 2026 Apr 18]. Available from: https://www.imf.org/external/datamapper/NGDPDPC@WEO/ OEMDC/ADVEC/WEOWORLD
5. International Monetary Fund. Data Explorer [homepage on the Internet]. 2025 [cited 2026 Apr 18]. Available from: https://data.imf.org/en/Data- Explorer?datasetUrn=IMF.RES:WEO(9.0.0)
6. Iran Food and Drug Administration. Pharmaceutical statistical yearbook [homepage on the Internet]. Tehran: Iran Food and Drug Administration; [cited 2026 Apr 18]. Available from: https://publicbi.fda.gov.ir/
7. OrchidLife Patient Support Program. Internal patient data on file. Tehran: CinnaGen Co.; 2025.
8. Noronha V, Abraham G, Patil V, Joshi A, Menon N, Mahajan A, et al. A real-world data of immune checkpoint inhibitors in solid tumors from India. Cancer Med. 2021;10(5):1525-34.
9. Institute of Cancer Research. UK cancer treatment ‘revolution’ as survey finds third of patients receiving modern precision treatments. 2019 Jul 16 [home-page on the Internet]. [cited 2026 Apr 18]. Available from: https://www.icr.ac.uk/about-us/icr-news/detail/uk-cancer-treatment-revolution-as-survey-finds-third-of-patients-receiving-modern-precision-treatments
10. Haslam A, Prasad V. Estimation of the percentage of US patients with cancer who are eligible for and respond to checkpoint inhibitor immunotherapy drugs. JAMA Netw Open. 2019;2(5):e192535.
11. Mameli C, Guadagni L, Orso M, Calcaterra V, Wasniewska MG, Aversa T, et al. Epidemiology of growth hormone deficiency in children and adolescents: a systematic review. Endocrine. 2024;85(1):91-8.
12. Kaplowitz P, Manjelievskaia J, Lopez-Gonzalez L, Morrow CD, Pitukcheewanont P, Smith A. Economic burden of growth hormone deficiency in a US pediatric population. J Manag Care Spec Pharm. 2021;27(8):1118-28.
13. Castellanos JM, Cooney R. Global variability in the management of inflammatory bowel disease: towards context-specific strategies. Cureus. 2025;17(11):e96156.
14. Social Security Organization of Iran. Drug list and insurance coverage [home-page on the Internet]. [cited 2026 Apr 18]. Available from: https://darman. tamin.ir/Forms/Public/Druglist.aspx
15. MS International Federation. Number of people with MS [homepage on the Internet]. Atlas of MS; 2022 [cited 2026 Apr 18]. Available from: https:// atlasofms.org/map/global/epidemiology/number-of-people-with-ms
16. MS International Federation. Proportion of people treated with each DMT. Atlas of MS; 2022 [homepage on the Internet]. [cited 2026 Apr 18]. Available from: https://atlasofms.org/table/global/disease-modifying-treatments/ proportion-of-people-treated-with-each-dmt
17. International Monetary Fund. GDP per capita, PPP. 2025 [homepage on the Internet]. [cited 2026 Apr 18]. Available from: https://www.imf.org/external/ datamapper/PPPPC@WEO
18. World Bank. GDP per capita, PPP. 2025 [homepage on the Internet]. [cited 2026 Apr 18]. Available from: https://data.worldbank.org/indicator/NY.GDP.PCAP.PP.CD
19. Bashari N, Safaei Lari M, Darvishi A, Daroudi R. Cost-utility analysis of pembrolizumab compared to other alternative immunotherapy and chemotherapy treatments for patients with advanced melanoma in Iran. Expert Rev Pharmacoecon Outcomes Res. 2024;24(2):273-84.
20. Tfayli AH, El-Halabi LN, Khuri FR. Global disparities in cancer care: bridging the gap in affordability and access to medications between high and low-income countries. Cancer. 2025;131(1):e35590.
21. Feldman SR, Bhutani T. Chronic plaque psoriasis in adults: overview of management. UpToDate. 2025. https://www.uptodate.com/contents/chronic-plaque-psoriasis-in-adults-overview-of-management
22. Moreland LW, Cannella A. Overview of the management of rheumatoid arthritis in adults. UpToDate. 2025 Aug 27. https://www.uptodate.com/contents/ overview-of-the-management-of-rheumatoid-arthritis-in-adults
23. Al Hashash J, Regueiro M. Medical management of moderate to severe Crohn disease in adults. UpToDate. 2025 Oct 31. https://www.uptodate.com/ contents/medical-management-of-moderate-to-severe-crohn-disease-in-adults
24. Market Research Intellect. Global adalimumab drug market size by indications, dosage forms, distribution channel, by Geographic Scope, and Future Trends Forecast. 2026 Jan [homepage on the Internet]. [cited 2026 Mar 17]. Available from: https:// www.marketresearchintellect.com/product/global-adalimumab-drug-market/
25. Truveta. Shifting trends in initiation of disease-modifying therapies for multiple sclerosis [homepage on the Internet]. 2025 [cited 2026 Apr 18]. Available from: https://www.truveta.com/blog/research/research-insights/shifting-trends-in-initiation-of-disease-modifying-therapies-for-multiple-sclerosis
26. Olek MJ, Mowry EM. Initial disease-modifying therapy for relapsing-remitting multiple sclerosis in adults. UpToDate. 2025 Aug 22. https://www.uptodate.com/contents/ initial-disease-modifying-therapy-for-relapsing-remitting-multiple-sclerosis-in-adults
27. Balasubramaniam M, Nandi N, Aswani-Omprakash T, Sebastian S, Sharma V, Deepak P, et al. Identifying care challenges as opportunities for research and education in inflammatory bowel disease in South Asia. Gastroenterology. 2022;163(5):1145-50.
Author for correspondence: Elmira Sayari, PharmD, CinnaGen, No. 34, Sepehr Street, Farahzadi Boulevard, Shahrak Gharb, Tehran, Iran |
Disclosure of Conflict of Interest Statement is available upon request.
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