The HSE University BRICS Competition Law and Policy Centre has released the initial findings of its annual study on biotechnological drugs within the BRICS markets, highlighting significant barriers to entry and opportunities for biosimilars.
The report calls for a sectoral study to address these barriers, focusing on fostering the development and accessibility of biologics and biosimilars. Biologics, synthesised from living cells, represent cutting-edge medical solutions for serious diseases but come with prohibitive costs. Biosimilars, priced 70-90% lower, offer an affordable alternative, making their increased availability in BRICS markets essential.
The biosimilars market is expected to reach $100 billion by the end of the decade, with significant opportunities for BRICS nations to lead. Experts, including the BRICS Working Group on Competition in Pharmaceutical Markets, advocate for removing regulatory barriers that hinder the circulation of biosimilars. Alexey Ivanov, underscored the importance of fostering healthy competition across the BRICS nations without allowing protectionist practices to obstruct progress.
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Competition authorities within the BRICS countries can play a pivotal role in reforming pharmaceutical market dynamics. The upcoming Working Group meeting in Kazan in March 2025 will present a roadmap for launching pilot projects aimed at reducing regulatory obstacles. India, a leader in biosimilar registration, is poised to take a prominent role in this initiative. Currently, India has registered 90 biosimilar products, compared to 45 in the US, showcasing its potential to capture at least 10% of the global biosimilars market by 2030.
Professor Samir Kulkarni of the Institute of Chemical Technology in Mumbai highlighted the immense potential for BRICS collaboration in the biosimilars sector. Co-operative efforts in developing biosimilars such as filgrastim and teriparatide could lower production costs by over 90%.
