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Enhancing Access to Affordable Healthcare: The Role of Biosimilars in Low- and Middle-Income Countries
Non-communicable diseases (NCDs) disproportionately impact populations in low- and middle-income countries (LMICs) compared to high-income countries (HICs), creating a critical healthcare challenge. With limited healthcare resources, LMICs face significant barriers in accessing essential treatments, particularly costly biologic medicines. Increasing the adoption of biosimilars—affordable alternatives to originator biologics—presents a promising solution to improve access to life-saving treatments in these regions.
In line with its mission to broaden access to life-saving biologics by making high-quality biosimilars available globally, Biocon Biologics recently published a review article in the Generics and Biosimilars Initiative (GaBI) Journal
Biocon Biologics took on this exercise to shift the spotlight to LMICs as most discussions around biosimilars focus on HICs. Drawing on data from emerging markets and interviews conducted across LMICs, this publication provides valuable insights into strategies that can be adopted to enhance the uptake of biosimilars in these regions to bridge the healthcare gap.
The Promise of Biosimilars in LMICs
In HICs, biosimilars have already demonstrated their value in reducing healthcare costs and increasing patient access to biologic treatments for diseases such as cancer, diabetes, and autoimmune disorders. By increasing competition in the market, biosimilars have driven down the prices of expensive biologics, allowing more patients to receive the treatments they need.
In LMICs, where healthcare budgets are often stretched and large segments of the population remain underserved, the introduction of biosimilars can be transformative. The publication titled “Increasing Adoption of Quality-Assured Biosimilars to Address Access Challenges in Low- and Middle-Income Countries” provides promising data on the potential and actual benefits of biosimilars in LMICs.
In Malaysia, for instance, insulin prices have dropped over 40%, and insulinization rates have improved by 30% since 2011, when biosimilars to RHI insulins were made available[1].
A 2016 study in Brazil estimated the impact of limited access to Trastuzumab on the mortality of HER2-positive metastatic breast cancer patients in the national health system (NHS). Of the 2,008 women diagnosed with advanced HER2-positive breast cancer, it was estimated that two years later, only 808 would be alive if they received only chemotherapy, 1,408 they received chemotherapy plus trastuzumab, and 1,576 if they received the gold standard of chemotherapy plus Trastuzumab and Pertuzumab[2].
Moreover, biosimilars can ease the financial burden on health systems by reducing the cost of biologic treatments, allowing governments and healthcare providers to allocate resources more efficiently. This can be especially impactful in LMICs, where healthcare systems are often underfunded and strained by high demand.
The report cites a survey among Malaysian oncologists, revealing that most (95%) agreed prescribing biosimilars would save healthcare costs, 91% believed it would increase the accessibility of biologics, and 88% felt it would stimulate competition in the biologics market[3].
[1] Biocon Biologics Limited. Strategic action. Transformational growth. Integratedannual report FY 2023 [homepage on the Internet]. [cited 2024 Oct 03. Available from: https://www.bioconbiologics.com/docs/Biocon_Biologics_Integrated_Annual_Report_2023.pdf
[2] Debiasi M, Reinert T, Kaliks R, Amorim G, Caleffi M, Sampaio C, et al. Estimation of premature deaths from lack of access to anti-her2 therapy for advanced breast cancer in the Brazilian public health system. J Global Oncol. 2016;3(3).
[3] Chong SC, Rajah R, Chow PL, Tan HC, Chong CM, Khor KY, et al. Perspectives toward biosimilars among oncologists: a Malaysian survey. J Oncol Pharm Pract. 2022: 10781552221104773.
Overcoming Challenges to Biosimilar Adoption in LMICs
Despite the potential benefits, there are several challenges that LMICs must overcome to fully realize the value of biosimilars. While many LMICs have established regulatory pathways for biosimilars, inconsistent regulatory requirements, a lack of harmonization across countries, and limited capacity for pharmacovigilance (the monitoring of drug safety post-approval) can hinder the adoption of quality-assured biosimilars. In some LMICs, biologics and biosimilars are relatively new concepts, and there is often uncertainty or skepticism about their use among healthcare providers and patients. Furthermore, policies that encourage the use of biosimilars are often underdeveloped or ineffective. Addressing these issues and fostering an environment that promotes the use of biosimilars will be essential to increasing their uptake.
Policy Recommendations for Expanding Biosimilar Access
The study by Biocon Biologics offers a series of policy recommendations that could help overcome these challenges and promote the wider adoption of biosimilars in LMICs.
- Strengthening regulatory systems: Key among these recommendations is the need to strengthen regulatory systems. By establishing clear, harmonized regulatory pathways and ensuring robust post-market surveillance, LMICs can build trust in the safety and efficacy of biosimilars.
- Strengthening pharmacovigilance: Strengthening pharmacovigilance systems is crucial to monitor and report suspected reactions or adverse events. Given the complexity of biosimilars, robust pharmacovigilance is essential to evaluate their long-term safety.
- Providing guidance for prescribing biosimilars and increasing education on biosimilars: Another important recommendation is the development of guidelines for prescribing biosimilars. These guidelines would help healthcare providers make informed decisions about when and how to prescribe biosimilars, ensuring that patients receive the most appropriate and cost-effective treatments. Education and awareness initiatives are also critical. By increasing understanding of biosimilars among healthcare providers, policymakers, and patients, LMICs can help dispel myths and misconceptions about these products, paving the way for broader adoption.
- Strengthening national policies to increase access and adoption of biosimilars: National policies that promote access to biosimilars should also be strengthened. Governments can play a pivotal role by implementing policies that encourage the use of biosimilars in public healthcare systems.
- Encouraging local manufacturing: Providing incentives for local manufacturing can facilitate stable supply and availability, and consequent access, to biosimilars in LMICs.
- Encouraging stakeholders’ initiatives promoting access to biosimilars: Collaboration among stakeholders—governments, pharmaceutical companies, healthcare providers, and patient advocacy groups—will be essential to driving the successful adoption of biosimilars in LMICs. Initiatives that bring these stakeholders together to address barriers and share best practices can create a supportive ecosystem for biosimilars.
A Path Towards Greater Access and Affordability
Biosimilars hold tremendous promise for improving healthcare access and affordability in LMICs. Biocon Biologics’ study published in the GaBI Journal provides a roadmap for expanding biosimilar access in LMICs. With the right strategies in place, LMICs can unlock the benefits of biosimilars, improving healthcare outcomes for millions of patients while easing the financial burden on health systems. In the long run, it will create a more equitable and sustainable global healthcare system.
