Summary:
A significant share of household spending in India goes toward healthcare, pushing an estimated 32–39 million people into poverty annually. Many families pressurised to sell property or pawn valuable jewellery to cover medical expenses, underscoring the urgent need for affordable healthcare solutions. This financial burden is worsened by limited insurance coverage, leading to greater economic strain and psychological stress. While advanced biologic treatments offer promising results, their high costs remain a major obstacle. Biosimilars, nearly identical and far more affordable versions of biologics presented a crucial solution, capable of reducing treatment costs by 50–75%.
India has emerged as a global leader in biosimilar production, having introduced its Biosimilar Guidelines in 2012 and revising them in 2016. Despite the approval of around 100 biosimilars, market entry remains hindered by patent ever greening tactics from multinational companies, using secondary patents and legal challenges to delay competition. Addressing these challenges requires a multi-faceted approach, including differential pricing, competitive regulation by the Competition Commission of India and tighter oversight from the Drugs Controller General of India. Expanding biosimilar use through public health programs like Ayushman Bharat, encouraging local manufacturing and streamlining regulatory approvals can boost adoption. With Indian pharmaceutical companies already supplying over 40% of the US’s generic drugs, leading to Rs. 19,09,242 crore (US$ 219 billion) in savings in 2022 and a similar savings potential exists for biosimilars. Strengthened policies and their enforcement can solidify India’s leadership in affordable healthcare, ensuring millions’ well-being and economic security.
Source: IBEF
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