As biologics research and development becomes more granular, biosimilars may wind up both less useful and profitable than boosters of the drug category once thought. According to experts, the first wave of biologic patent expiry is almost over — and a new set of expirations starting in 2024 will determine whether biosimilars will have as big an impact in the U.S. as they have in the European Union. There has been a large number of biosimilar approvals in recent years, according to business intelligence firm GlobalData. The EU “experienced this biosimilar wave ahead of regions such as the US and Asia-Pacific because the EU created the first biosimilar-specific approval pathway,” according to Quentin Horgan, GlobalData’s senior drugs database analyst. Approvals of biosimilars have slowed down in recent years. Partially due to that fact, a June 2021 report from the IQVIA Institute observed that “in the short-term (2021-2023) the European market provides a relatively low opportunity for biosimilars with only a small number of brands losing exclusivity. However, this will change dramatically between 2024 and 2029 as approximately 100 biologic medicines will lose exclusivity.”
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