Biosimilars in low- and middle-income countries

Biosimilars offer a viable route to treatment for those with non-communicable diseases (NCDs) living in low- and middle-income countries (LMICs). A review article published in GaBI Journal titled ‘Increasing adoption of quality-assured biosimilars to address access challenges in low- and middle-income countries,’ offers insights into the benefits of biosimilars for better access to biologics in LMICs, focusing on data from selected emerging markets (Brazil, Colombia, Malaysia, Mexico, Nigeria, Taiwan, and Turkey).

Most reports on biosimilars focus on their presence in high-income countries (HICs). However, they have great potential to make a difference in LMICs, where healthcare budgets are even more constrained. Biosimilars can help increase patients’ access and affordability to lifesaving biological medicines by promoting pricing competition with the originator biologicals/reference products (RPs).

For the review, the authors conducted several surveys and a literature search. They use these findings to outline key aspects of NCDs, including cancer and diabetes. The review describes the role of biosimilars in providing more affordable treatment options for patients, as well as the current status of biosimilarsregulation in Europe and the US, introducing the concept of interchangeability. The authors note that the framework for biosimilars regulation in LMICs is continuously evolving, and many LMICs have established abbreviated clinical development pathways for biosimilars evaluation, often following the frameworks of WHO and EMA. Despite this step towards facilitating access to biosimilars, comparability pathways for biosimilars are not always implemented effectively in LMICs, due to ambiguity in the regulatory oversight.

Overall, the review highlights that biosimilars, offering cost-effective alternatives to RPs, present significant benefits for LMICs. They can reduce treatment costs, increase patient access, and promote market competition. For instance, in Malaysia, the introduction of biosimilars led to a 40% drop in insulin prices and a 30% increase in insulinization rates. Similarly, studies in Brazil and China highlight the potential of biosimilars like trastuzumab in improving survival rates for cancer patients and lowering treatment costs. Surveys also reveal that physicians in LMICs consider biosimilars as vital for reducing healthcare costs and expanding access to care.

Despite these benefits, several barriers hinder biosimilar adoption in LMICs. Regulatory challenges include underdeveloped frameworks, insufficient pharmacovigilance, and imprecise use of interchangeability standards, particularly in regions like Africa, where substandard medicines are prevalent. Inappropriate labelling of non-innovator biotherapeutics as biosimilars further erodes confidence in their safety and efficacy. Countries like China have a significant presence of such products, complicating the market.

Other barriers include import dependency, which leaves LMICs vulnerable to shortages and counterfeit medicines, as well as low awareness among healthcare professionals and patients, leading to mistrust. Surveys indicate that misinformation about biosimilars persists among pharmacists and patients, often stemming from healthcare providers' lack of knowledge. Finally, the absence of effective policies and incentives in LMICs discourages hospitals from adopting biosimilars into their formularies.

To improve biosimilar access, the review highlights that LMICs must enhance education, build regulatory capacity, foster local manufacturing partnerships, and combat counterfeit medicines. Clear policies and incentives promoting biosimilars are essential for realizing their potential to improve healthcare affordability and accessibility in LMICs.

The review also underscores that access to quality-assured biosimilars in LMICs can expand treatment options and reduce healthcare costs. However, tailored policies are essential to address local challenges and ensure safety, affordability, and widespread adoption.

Key recommendations include strengthening regulatory systems, enhancing pharmacovigilance, improving prescribing guidelines and education, strengthening national policies, encouraging local manufacturing and increasing stakeholder led initiatives.

Beyond affordability, stakeholders should consider the following when selecting biosimilars: product quality, regulatory approvals pathway, adverse events and real-world evidence, packaging and delivery, manufacturer capabilities and additional services/education.

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Reference
1. Paul P, Kapur R, Mittra S, Shah N, Rao GK, Erick ME, Umesh S, Athalye SN. Increasing adoption of quality-assured biosimilars to address access challenges in low- and middle-income countries. Generics and Biosimilars Initiative Journal (GaBI Journal). 2024;13(2):40-54. doi:10.5639/gabij.2024.1302.008

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