118 biologics are expected to lose patent protection, representing a $232Bn of sales

• Over the next decade (2025–2034), 118 biologics are expected to lose patent protection, presenting a $232Bn opportunity for biosimilars.
• Only 12 molecules set to lose patent protection from 2025 to 2034 have biosimilars in development as of June 2024, with the remaining 106 biologic patent expiries representing a ‘biosimilar void.’
• Factors influencing biosimilar development are market potential, timing of patent expiry, disease area, patient population size, and complexity of manufacturing and clinical testing.
• To ensure the sustainability of the biosimilar market and the savings and affordability benefits are fully realized by the healthcare system and patients, stakeholders must address the challenges contributing to a biosimilar void.

• The next decade presents significant opportunity for biosimilars as 118 biologics are expected to lose patent protection from 2025 to 2034, with loss of exclusivity (LoE) opportunities for these biologics totaling $234Bn.
• Average sales exposure per year over the next decade is $23Bn and 12 biologics losing patent protection on average each year, compared to $9Bn over the last decade and five expiries highlighting the accelerating pace of patent expiries in biologics.
• Looking at historic patent expiries shows that biosimilar competition is not a certainty for all biologics, and increasing pressures on biosimilar developers may limit the future potential of biosimilars.

• Of the 118 biologic patent expiries over the next decade, 10% currently have biosimilars in development and could face competition, while 90% have no pipeline limiting savings potential to the healthcare system.
• Biosimilar development is concentrated in biologics with high sales potential and near-term expiries.
• Thirteen high sales, near term expiries have no biosimilar development, indicating that sales and expiry timing are not the only factors influencing biosimilar developer decision-making.

Continue at:  https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/assessing-the-biosimilar-void-in-the-us

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