Biologic drugs — also known as biopharmaceuticals — are among the most effective treatments for serious conditions such as cancer, diabetes, and rheumatoid arthritis. However, their complex production processes make them extremely expensive: a year of treatment can cost hundreds of thousands of dollars, with individual doses sometimes priced in the millions. As a result, these advanced therapies remain out of reach for most patients, particularly in low- and middle-income countries.
Biosimilars, which are essentially generic versions of biologic drugs, offer a way to dramatically reduce treatment costs — by as much as 70 to 90 percent — thereby expanding access to essential therapies. This is especially critical in developing countries, where adopting biosimilars allows health systems to use public funds more efficiently and extend medical coverage to a wider population.
Despite their potential, biosimilars face significant hurdles when entering the market. Regulatory pathways can be overly complex, intellectual property laws may lack clarity or balance, and competition policies are often insufficiently enforced. These challenges are further compounded by anti-competitive practices from large pharmaceutical companies that control patents on original biologics.
Addressing these issues requires coordinated international action. BRICS countries, with their growing scientific and manufacturing capabilities, are well-positioned to collaborate. In this context, the BRICS Competition Law and Policy Centre and the Institute of Chemical Technology in Mumbai are conducting a comparative analysis of biosimilar regulatory frameworks across BRICS nations.
As part of this effort, the BRICS Centre has launched a survey targeting pharmaceutical industry stakeholders to identify barriers to market entry for both biologics and biosimilars. Special attention is being paid to anti-competitive behavior and other factors limiting access to these vital medicines. The findings will form a comprehensive analytical report by the Centre.
