New Delhi: Biocon Biologics has released the results of a comprehensive study aimed at enhancing the adoption of biosimilars in low- and middle-income countries (LMICs).
The findings, which have been published in the Generics and Biosimilars Initiative (GaBI) Journal, propose a series of actionable strategies to overcome barriers to biosimilar uptake and expand access to affordable, high-quality healthcare solutions for underserved populations.
The peer-reviewed article, titled “Increasing Adoption of Quality-Assured Biosimilars to Address Access Challenges in Low- and Middle-Income Countries,” outlines six core policy recommendations aimed at increasing the accessibility and adoption of biosimilars in LMICs. These include strengthening regulatory systems to streamline approvals and reduce redundancies, implementing supportive national policies that integrate biosimilars into healthcare systems, and promoting local manufacturing to reduce dependency on imports.
Additionally, the report emphasizes the importance of providing clear prescribing guidelines and education for healthcare professionals to support the safe and effective use of biosimilars. It also advocates for stakeholder collaborations, bringing together governments, healthcare providers, and industry to raise awareness and promote biosimilar benefits. Finally, the article calls for robust pharmacovigilance systems to ensure safety monitoring and maintain confidence in these products.
Susheel Umesh, Chief Commercial Officer of Emerging Markets at Biocon Biologics, emphasized that LMICs often face constrained healthcare systems, and clarity in regulatory frameworks is crucial to avoid delays in accessing quality-assured, affordable medicines. “Regulatory agencies must consider a paradigm shift towards eliminating redundancies in the approval processes and fast-track commercialization of quality-assured biosimilars. Through this article, we have provided recommendations that can lead to improved adoption of biosimilars in countries with limited resources and the most critical need for cost-effective, high-quality alternatives to modern therapies,” stated Umesh.
The study further underscores the urgent need for regulatory reforms in LMICs, where healthcare resources are particularly limited, and the burden of non-communicable diseases (NCDs) is high. NCDs such as cancer and diabetes account for 74% of global deaths, with 41 million people succumbing to them annually. In LMICs, 77% of NCD-related deaths occur, indicating the immense pressure on these regions’ healthcare systems.
Dr. Uwe Gudat, Chief Medical Officer at Biocon Biologics, elaborated on the impact of NCDs in LMICs and how biosimilars could help mitigate this burden. “Non-communicable diseases disproportionately impact low- and middle-income countries, 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,” he noted.
The report draws attention to the significant benefits biosimilars can bring to LMICs, similar to their success in high-income countries (HICs) where they have demonstrated their value in reducing healthcare costs and increasing patient access to biologic treatments for diseases such as cancer, diabetes, and autoimmune disorders. The introduction of biosimilars in LMICs can be transformative, helping these regions stretch their often-limited healthcare budgets while addressing large unmet medical needs.
The article calls for a concerted effort to promote the use of biosimilars as a viable and effective option in treating NCDs in resource-constrained settings. Biocon Biologics, through its strategic focus on accessibility and affordability, is actively working to bridge the disparities in healthcare access between HICs and LMICs. Its biosimilar portfolio provides cost-effective alternatives to expensive biologic drugs, thereby making advanced medical treatments more accessible to patients who would otherwise be unable to afford them.