Biocon Biologics report explores pathways to increase biosimilar adoption in low- and middle-income countries

Biocon Biologics, a global biosimilars company, has released the findings of a study focused on improving the adoption of biosimilars in low- and middle-income countries (LMICs). The study, commissioned by Biocon Biologics and developed in collaboration with Clarivate, highlights strategies to expand access to affordable healthcare solutions through biosimilars. The findings have been published in the Generics and Biosimilars Initiative (GaBI) Journal under the title, “Increasing Adoption of Quality-Assured Biosimilars to Address Access Challenges in Low- and Middle-Income Countries.”

The study outlines six policy recommendations aimed at increasing access to and usage of quality-assured biosimilars in LMICs. These recommendations include strengthening regulatory systems, enhancing national policies to support biosimilar adoption, encouraging local manufacturing, providing guidance on biosimilar prescribing, promoting education on biosimilars, and reinforcing pharmacovigilance measures.

Susheel Umesh, Chief Commercial Officer for Emerging Markets at Biocon Biologics, highlighted the importance of clear regulatory frameworks to ensure timely access to affordable medicines, particularly in LMICs. He stated, “Clarity in regulatory frameworks and pathways help in preventing delays in accessing quality-assured, affordable medicines. This is important especially in low- and low-middle-income countries (LMICs) that already struggle with constrained healthcare systems. Regulatory agencies must consider a paradigm shift towards eliminating redundancies in the approval processes and fast-track commercialization of quality-assured biosimilars.”

The report emphasises the role of biosimilars in improving patient outcomes in LMICs, where healthcare resources are often limited. Dr Uwe Gudat, Chief Medical Officer at Biocon Biologics, commented, “Non-communicable diseases (NCDs) disproportionately impact low- and middle-income countries (LMICs), where healthcare resources are particularly limited. Our study underscores the potential of biosimilar products to expand access to essential medicines in these regions. By offering more affordable alternatives to originator biologics, biosimilars can significantly improve patient outcomes.”

The study points out that non-communicable diseases, such as cancer and diabetes, are responsible for 74 per cent of global deaths, with 41 million people dying annually from these conditions. Of these deaths, 77 per cent occur in LMICs, where access to affordable biologic treatments remains a challenge. Biosimilars offer a cost-effective alternative to originator biologics and could help improve patient outcomes by increasing access to essential medicines.

While high-income countries (HICs) have demonstrated the value of biosimilars in reducing healthcare costs and improving patient access, LMICs continue to face budgetary constraints. The introduction of biosimilars in these regions has the potential to transform healthcare access, making advanced treatments more affordable.

Biocon Biologics is committed to bridging the healthcare access gap between high-income and low- and middle-income countries. The company’s biosimilars provide cost-effective alternatives to expensive biologic drugs, contributing to improved patient outcomes and a more sustainable use of healthcare resources.

The full article is available on the GaBI Journal website.