The World Health Organization (WHO) has highlighted its role in expanding global access to biosimilars in a February 2025 feature article, ‘Biosimilars: expanding access to essential biologic therapies’ [1].
The article outlines how biological medicines have transformed the treatment of chronic and life-threatening conditions such as cancer, autoimmune diseases, and diabetes. These advanced therapies offer significant advantages over conventional drugs in efficacy, safety, and convenience However, their high costs have created major barriers to access, particularly in low- and middle-income countries (LMICs). Biosimilars, cost-effective alternatives to biological medicines, are helping address this challenge by making essential treatments more affordable.
WHO’s role in promoting biosimilars
The WHO considers biosimilars crucial for expanding global access to life-saving biological medicines,especially in LMICs. Through its Essential Medicines List (EML), WHO evaluates and endorses quality-assured biosimilars as safe, effective, and cost-efficient alternatives to originator biologicals. The WHO Prequalification Program strengthens confidence in biosimilars, facilitating procurement by UN agencies and national healthcare systems, thereby improving affordability and availability.
Additionally, WHO plays a key role in setting international standards for biological products through the Expert Committee on Biological Standardization (ECBS), ensuring the consistent quality, safety, and efficacy of biosimilars worldwide [2].
The organization also promotes regulatory harmonization to streamline biosimilar approval and adoption across different regions. It provides guidelines to assist national regulatory authorities in evaluating biosimilars based on rigorous quality, safety, and efficacy criteria [3, 4]. Furthermore, WHO establishes International Biological Reference Materials, which serve as benchmarks for ensuring product comparability and potency across manufacturers and countries.
As of 2023, WHO's EML includes 81 biological therapies, accounting for over 15% of all listed essential medicines. The inclusion of biosimilars in the EML has significantly reduced treatment costs for critical conditions such as breast cancer and lymphoma, as seen with trastuzumab and rituximab biosimilars. Countries like Brazil, India, and South Africa have successfully expanded patient access by approving and integrating these biosimilars into national healthcare systems. WHO’s ongoing efforts, through education, regulatory support, and collaborative initiatives, continue to enhance equitable access to essential medicines worldwide.
Biosimilars and the Essential Medicines List
The WHO highlights the example of trastuzumab biosimilars, used to treat HER2-positive breast cancer, as a game-changer. Originally, trastuzumab cost over US$20,000 per year, making it unaffordable for many patients in LMICs. After the WHO prequalified the first trastuzumab biosimilar in 2019, costs decreased by around 65%, enabling countries like India, Brazil, and South Africa to expand access to life-saving cancer treatments.
Similarly, WHO’s inclusion of adalimumab, a key treatment for rheumatoid arthritis and other inflammatory diseases, has reinforced the role of biosimilars in improving affordability.
Overcoming barriers to adoption
Despite their benefits of biosimilars, the WHO acknowledges that challenges remain in biosimilar adoption.Concerns about switching from originator biologicals, regulatory variations between countries, and limitedawareness among healthcare professionals have slowed uptake in some regions.
To address these issues, WHO recommends that quality-assured biosimilars be considered interchangeable with their reference biologicals, reassuring healthcare providers and patients. It also advocates for expanded Prequalification Programs and ongoing regulatory improvements to facilitate broader adoption.
The WHO strongly advocates for the use of quality-assured generic and biosimilar medicines to improve accessibility and healthcare sustainability, particularly in LMICs. However, challenges such as regulatory barriers, limited awareness, and manufacturing constraints hinder widespread adoption. Coordinated efforts in regulation, education, and infrastructure investment are essential to ensure broader acceptance and utilization.
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References
1. Biosimilars: expanding access to essential biologic therapies. Available from: https://www.who.int/news/item/13-02-2025-biosimilars--expanding-access-to-essential-biologic-therapies
2. GaBI Online - Generics and Biosimilars Initiative. Highlights of the revised WHO guideline on evaluation of biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Apr 11]. Available from: www.gabionline.net/reports/highlights-of-the-revised-who-guideline-on-evaluation-of-biosimilars
3. GaBI Online - Generics and Biosimilars Initiative. WHO’s revised guideline to safe and effective biosimilar products [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Apr 11]. Available from: www.gabionline.net/guidelines/who-s-revised-guideline-to-safe-and-effective-biosimilar-products
4. GaBI Online - Generics and Biosimilars Initiative. WHO revised guidelines for biosimilars: scientific background [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Apr 11]. Available from: www.gabionline.net/biosimilars/research/who-revised-guidelines-for-biosimilars-scientific-background
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