Record-Breaking FDA Biosimilar Approvals to Create Opportunities for Drug Developers & Manufacturers

FDA biosimilar approvals reached a record 19 in 2024, with projections indicating that 2025 could surpass this milestone trend. This presents a golden opportunity for Contract Manufacturing Organizations (CMOs) specializing in biologics, as more blockbuster drugs approach patent expiration and regulatory barriers to entry diminish, says GlobalData, a leading data and analytics company.

Kathryn Kinch, Senior Pharma Product Manager at GlobalData, comments: “Increased approvals of biosimilars are likely to lower biologic prices, enhancing consumer demand and competition among drug companies, which will benefit CMOs through higher biosimilar volumes.”

GlobalData’s Bio/Pharmaceutical Outsourcing Report notes that momentum for biosimilars is set to accelerate. Patents for 14 biologics expired in 2024, including major products like UCB SA’s Cimzia and Johnson & Johnson’s Simponi. Even more biologics – 18 – will lose patent protection in 2025, paving the way for a new wave of biosimilar entrants, including Amgen’s Prolia and Roche’s Perjeta.

In addition to the increase in biosimilar approvals, the report showcases growing importance of strong relationships in clinical supply chains, major pharmaceutical companies’ intentions to establish manufacturing facilities in the US, highlighted by Novartis‘ announcement of a $23 billion investment, and the initial 100 days of US President Trump’s administration and the potential effects on pharmaceutical investments and tariff concerns in the US.

In the report, GlobalData Pharma Analyst Katarina Zahedi also shares highlights from the Clinical Trial Supply (CTS) New England conference, such as “the importance of understanding the scope of the trial, geographic location, the demand for and the type of drug, and timeframe for trial start-up – as these are all factors that will influence cost. For example, a biologic is more costly to develop than drugs of other molecule types, as it requires longer development timelines and specialized requirements for trials and manufacturing due to their complexity.”

The Bio/Pharmaceutical Outsourcing Report is a monthly analysis of news and trends affecting pharmaceutical contract manufacturing organizations. The report lists the latest contract manufacturing agreements, opportunities and threats for CDMOs, M&A and financing of CDMOs, and emerging regulatory news.

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