Record-breaking FDA biosimilar approvals to create opportunities

The US Food and Drug Administration’s (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 pharma analytics company GlobalData.

Kathryn Kinch, senior pharma product manager at GlobalData, commented: “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.”