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Patent expiry of blockbuster biologics
The expiry of patents on major biologic drugs known as blockbusters can drive the biosimilars market growth. When the original manufacturer's patent expires, it offers opportunity for other companies to develop and market biosimilar versions. Notable patent expires in recent years have included Humira, Remicade, Herceptin, Rituxan and MabThera. For instance, AbbVie's Humira, the world's top-selling prescription drug, had worldwide sales of over US$ 20 billion in 2020, according to the STAT Medical Research Guide. With Humira losing exclusivity in Europe in 2018 and the U.S. in 2023, this has encouraged many biosimilar manufacturers to enter the market. In the European Union, biosimilar competition has led to price reductions as high as 80% off the original biologic drug. Greater patient access as well as savings for healthcare systems boosts adoption of lower-cost biosimilars.
According to the WHO Essential Medicines and Health Products List, between 2023 and 2026, blockbusters worth a combined estimated US$ 72 billion in annual sales are forecast to face upcoming patent cliffs. ,. This includes Enbrel, Lantus, Avastin and Harvoni. As more high-profile biologics complete their exclusivity period, their biosimilar counterparts are expected to capture greater market shares over the next decade.
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